RELATED APPLICATIONSThis application is a continuation of co-pending U.S. patent application Ser. No. 17/187,527, which was filed on Feb. 26, 2021, which is a continuation of U.S. patent application Ser. No. 16/827,677, which was filed on Mar. 23, 2020, which is a continuation of U.S. patent application Ser. No. 15/464,199, which was filed on Mar. 20, 2017 and claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62/313,707 filed on Mar. 26, 2016 titled “Apparatus & Systems For Minimally Invasive Dissection of Tissues via Cannula” and further claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62/409,575 filed on Oct. 18, 2016 and titled “Apparatus, Systems, and Methods for Minimally Invasive Dissection of Tissues.” Each of the aforementioned applications is hereby incorporated herein by reference in its entirety.
SUMMARYExamples of certain preferred embodiments and implementations of the invention are disclosed below in connection with the following numbered paragraphs.
- 1. An electrosurgical device configured for deployment through a cannula, comprising:
- a lysing tip configured for delivery of electrosurgical energy, wherein the lysing tip comprises:
- an energy delivery side configured to receive and deliver electrosurgical energy for one or both of tissue dissection and modification; and
- an orientational-deployment side opposite from the energy delivery side, wherein the orientational-deployment side is configured to allow for the lysing tip to be repositioned between a delivery configuration in which the lysing tip can be positioned within a lumen of the cannula with the energy delivery side facing an interior surface of the lumen and a treatment configuration in which the lysing tip is positioned outside of the cannula such that the energy delivery side extends at least substantially perpendicular to an axis of the cannula; and
- a deployment assembly coupled with the orientational-deployment side of the lysing tip, wherein the deployment assembly is configured to allow for selective repositioning between the delivery configuration and the treatment configuration.
- 2. The electrosurgical device of example 1, wherein the lysing tip is configured is configured such that the energy delivery side extends at least substantially parallel to the axis of the cannula in the delivery configuration.
- 3. The electrosurgical device of example 1, wherein the lysing tip is configured such that the energy delivery side extends at an acute angle relative to the axis of the cannula in the delivery configuration.
- 4. The electrosurgical device of example 1, wherein the deployment assembly comprises a first actuation rod and a second actuation rod coupled with the lysing tip.
- 5. The electrosurgical device of example 4, further comprising a retraction guide configured to facilitate repositioning of the lysing tip between the treatment configuration and the delivery configuration.
- 6. The electrosurgical device of example 5, wherein the retraction guide is configured to provide a restorative force to the lysing tip by contacting the cannula when the lysing tip is repositioned from the treatment configuration to the delivery configuration.
- 7. The electrosurgical device of example 6, wherein the retraction guide comprises a spring positioned on at least one of the first actuation rod and the second actuation rod.
- 8. The electrosurgical device of example 4, further comprising at least one canal configured to supply fluids to a surgical site adjacent to the lysing tip during a surgical procedure.
- 9. The electrosurgical device of example 8, wherein the at least one canal is configured to be selectively extended towards the lysing tip and withdrawn from the lysing tip.
- 10. The electrosurgical device of example 4, wherein the first actuation rod comprises a first hinge, and wherein the second actuation rod comprises a second hinge.
- 11. The electrosurgical device of example 10, wherein the first hinge and the second hinge are configured to allow the lysing tip to be selectively rotated at least one of above and below a cross-sectional profile of an opening at a distal end of the cannula in the treatment configuration.
- 12. The electrosurgical device of example 1, further comprising at least one energy window formed on at least one of an upper surface and a lower surface of the lysing tip.
- 13. The electrosurgical device of example 12, wherein the at least one energy window comprises a plurality of energy windows.
- 14. The electrosurgical device of example 13, wherein at least a subset of the plurality of energy windows are at least one of physically and energetically isolated from one another.
- 15. The electrosurgical device of example 14, wherein the at least a subset of the plurality of energy windows is configured to deliver a modality of energy that differs from at least a second subset of the plurality of energy windows.
- 16. The electrosurgical device of example 1, wherein the lysing tip comprises an antenna configured to provide location data regarding the lysing tip.
- 17. The electrosurgical device of example 16, wherein the antenna comprises an RFID tag.
- 18. The electrosurgical device of example 1, wherein the lysing tip comprises a bipolar lysing tip configured to deliver bipolar electrosurgical energy, and wherein the lysing tip comprises a first set of lysing elements and a second set of lysing elements, wherein the first set of lysing elements is electrically isolated from the second set of lysing elements.
- 19. The electrosurgical device of example 18, wherein the lysing tip comprises a first linking member electrically coupled to the first set of lysing elements and a second linking member electrically coupled to the second set of lysing elements, and wherein the first linking member is electrically isolated from the second linking member.
- 20. An electrosurgical system, comprising:
- an electrosurgical device comprising a lysing tip having a first end and a second end opposite from the first end, wherein the lysing tip comprises:
- a plurality of protrusions; and
- at least one lysing segment positioned between at least two adjacent protrusions in the plurality of protrusions;
- a cannula configured for delivery of the electrosurgical device; and
- a deployment assembly coupled with the electrosurgical device, wherein the electrosurgical device and the deployment assembly are configured such that the at least one lysing segment is positioned to face an interior wall of the cannula during delivery of the electrosurgical device, and such that the at least one lysing segment can be rotated after extending through a distal end of the cannula to allow at least one of the first end and the second end to protrude beyond a cross-sectional profile of an opening at the distal end.
- 21. The electrosurgical system of example 20, wherein the electrosurgical device and the deployment assembly are configured such that the at least one lysing segment can be rotated after extending through a distal end of the cannula to allow both the first end and the second end of the lysing tip to protrude beyond a cross-sectional profile of the opening at the distal end.
- 22. The electrosurgical system of example 20, further comprising a second cannula comprising a cross-sectional area greater than a cross-sectional area of the cannula, wherein the second cannula is configured to be positioned outside the cannula during delivery of the electrosurgical device.
- 23. The electrosurgical system of example 22, wherein the electrosurgical device is configured such that the plurality of protrusions is unable to be fully received within the second cannula.
- 24. The electrosurgical system of example 20, further comprising a spot coagulator configured to extend through the cannula and deliver electrosurgical energy therethrough.
- 25. The electrosurgical system of example 24, wherein the spot coagulator is configured to be selectively movable relative to the lysing tip.
- 26. The electrosurgical system of example 20, further comprising means for fixing a rotational orientation of the lysing tip relative to the cannula.
- 27. The electrosurgical system of example 26, wherein the means for fixing a rotational orientation of the lysing tip relative to the cannula is positioned on the cannula.
- 28. The electrosurgical system of example 26, wherein the means for fixing a rotational orientation of the lysing tip relative to the cannula comprises at least one slot formed in a distal end of the cannula.
- 29. The electrosurgical system of example 28, wherein the at least one slot is configured to receive at least a portion of the lysing tip therein in a treatment configuration in which the lysing tip is positioned outside of the cannula such that the energy delivery side extends at least substantially perpendicular to the axis of the cannula.
- 30. The electrosurgical system of example 20, wherein the at least one lysing segment is made up of a cermet material.
- 31. The electrosurgical system of example 20, wherein the deployment assembly comprises:
- a first actuation rod; and
- an intermediate hinge member coupled with the first actuation rod and coupled with the lysing tip, wherein the intermediate hinge member is configured such that actuation of the first actuation rod results in pivoting of the lysing rod between a delivery configuration in which the lysing tip can be positioned within a lumen of the cannula with the at least one lysing segment facing an interior surface of the lumen and a treatment configuration in which the lysing tip is positioned with at least one of the first end and the second end protruding beyond a cross-sectional profile of the opening of the cannula at the distal end.
- 32. The electrosurgical system of example 31, wherein the intermediate hinge member is coupled with the lysing tip in between two opposing ends of the lysing tip.
- 33. The electrosurgical system of example 32, wherein the lysing tip further comprising a linking member positioned along a proximal side of the lysing tip, and wherein the intermediate hinge member is coupled with the linking member.
- 34. The electrosurgical system of example 32, wherein the deployment assembly further comprises a second actuation rod.
- 35. The electrosurgical system of example 34, wherein the second actuation rod is pivotably coupled to the lysing tip.
- 36. The electrosurgical system of example 35, wherein the second actuation rod is pivotably coupled to the lysing tip at one end of the two opposing ends of the lysing tip.
- 37. The electrosurgical system of example 31, wherein the intermediate hinge member is coupled with the lysing tip at one end of two opposing ends of the lysing tip.
- 38. The electrosurgical system of example 37, wherein the deployment assembly further comprises a second actuation rod.
- 39. The electrosurgical system of example 38, wherein the second actuation rod is configured to advance and withdraw the lysing tip within the cannula.
- 40. The electrosurgical system of example 39, wherein the second actuation rod is coupled with the lysing tip along a central portion of the lysing tip between the two opposing ends.
- 41. A surgical system, comprising:
- a surgical lysing tip comprising:
- a treatment side; and
- an orientational-deployment side opposite from the treatment side, wherein the surgical lysing tip comprises a lysing tip axis extending at least substantially along the treatment side and along the orientational-deployment side;
- a cannula configured for delivery of the surgical lysing tip, wherein the cannula comprises a cannula axis; and
- a deployment assembly coupled with the orientational-deployment side of the surgical lysing tip and configured to pivot the surgical lysing tip following delivery of the surgical lysing tip through a distal opening of the cannula, wherein the deployment assembly is configured to allow the surgical lysing tip to be delivered through the cannula along the cannula axis such that the lysing tip axis is at least substantially aligned with the cannula axis during delivery, and wherein the deployment assembly is configured to allow the surgical lysing tip to be selectively pivoted after the surgical lysing tip has passed through the distal opening such that the lysing tip axis is positioned at an angle with respect to the cannula axis and such that at least one of two opposing ends of the surgical lysing tip defining the lysing tip axis protrudes beyond a cross-sectional profile of the distal opening of the cannula.
- 42. The surgical system of example 41, wherein the surgical system is configured to allow the surgical lysing tip to be selectively pivoted after the surgical lysing tip has passed through the distal opening such that the lysing tip axis is positioned at an angle with respect to the cannula axis and such that both of the two opposing ends of the surgical lysing tip defining the lysing tip axis protrude beyond the cross-sectional profile of the distal opening of the cannula.
- 43. An electrosurgical device, comprising:
- a lysing tip comprising:
- a plurality of beads;
- at least one lysing member defining at least one lysing segment extending between each pair of adjacent beads; and
- a tunnel extending at least partially through each of the plurality of beads, wherein the at least one lysing member is positioned to extend at least partially through the tunnel to define the at least one lysing segment between each pair of adjacent beads.
- 44. The electrosurgical device of example 43, wherein each of the plurality of beads is non-symmetrical relative to an axis defined by the at least one lysing member.
- 45. The electrosurgical device of example 43, wherein the lysing tip comprises a plurality of lysing segments.
- 46. The electrosurgical device of example 44, wherein each of the plurality of lysing segments is formed by a single lysing member.
- 47. The electrosurgical device of example 44, wherein at least one lysing segment of the plurality of lysing segments extends at an angle relative to at least one other lysing segment of the plurality of lysing segments.
- 48. The electrosurgical device of example 47, wherein the plurality of lysing segments extend in an arced shape along a treatment side of the lysing tip.
- 49. The electrosurgical device of example 48, wherein at least a first lysing segment of the plurality of lysing segments extends in a first direction, wherein at least a second lysing segment of the plurality of lysing segments extends in a second direction angled towards a first side of the lysing tip relative to the first direction, and wherein at least a third lysing segment of the plurality of lysing segments extends in a third direction angled towards a second side of the lysing tip opposite from the first side relative to the first direction.
- 50. The electrosurgical device of example 43, wherein each of at least a subset of the plurality of beads comprises a plurality of facets formed thereon.
- 51. The electrosurgical device of example 50, wherein each of the at least a subset of the plurality of beads comprises facets formed on leading surfaces of the beads, and wherein the facets are configured to facilitate movement of the lysing tip between tissue layers during a surgical procedure.
- 52. The electrosurgical device of example 51, wherein each of the at least a subset of the plurality of beads comprises a first facet formed on an upper leading surface and a second fact formed on a lower leading surface, and wherein the upper leading surface is angled towards the lower leading surface so as to form a wedge shape.
- 53. The electrosurgical device of example 43, wherein each of at least a subset of the plurality of beads comprises a substantially flattened trailing end.
- 54. The electrosurgical device of example 53, wherein the at least a subset of the plurality of beads comprises a substantially frusto-ellipsoidal shape.
- 55. The electrosurgical device of example 43, wherein each of at least a subset of the plurality of beads comprises a substantially ellipsoidal shape.
- 56. The electrosurgical device of example 55, wherein each of the plurality of beads comprises a substantially ellipsoidal shape.
- 57. The electrosurgical device of example 43, further comprising a first actuation rod coupled adjacent to a first end of the lysing tip and a second actuation rod coupled adjacent to a second end of the lysing tip opposite from the first end.
- 58. The electrosurgical device of example 57, wherein the first actuation rod and the second actuation rod are configured to pivot the lysing tip between a delivery configuration and a treatment configuration.
- 59. The electrosurgical device of example 58, wherein the lysing tip is configured to be delivered through a cannula with the first actuation rod and the second actuation rod extending through the cannula, wherein the electrosurgical device is configured such that the lysing tip cannot be fully received in the cannula in the treatment configuration.
- 60. The electrosurgical device of example 59, wherein the electrosurgical device is configured so as to extend the lysing tip at an angle relative to an axis of the cannula in the delivery configuration, and wherein the electrosurgical device is configured such that the lysing tip can be fully received in the cannula in the delivery configuration.
- 61. The electrosurgical device of example 60, wherein at least one of the first actuation rod and the second actuation rod comprises a first bend at or near a distal end of the at least one of the first actuation rod and the second actuation rod.
- 62. The electrosurgical device of example 61, wherein the first bend defines a widened area for receipt of a portion of the lysing tip during repositioning of the lysing tip between the treatment configuration and the delivery configuration.
- 63. The electrosurgical device of example 62, wherein the at least one of the first actuation rod and the second actuation rod comprises a second bend positioned distally of the first bend, and wherein the second bend extends in a direction opposite of the first bend.
- 64. The electrosurgical device of example 58, wherein the first actuation rod comprises a first opening for receiving a first end of the lysing member therethrough, and wherein the second actuation rod comprises a second opening for receiving a second end of the lysing member opposite from the first end therethrough.
- 65. The electrosurgical device of example 64, wherein the first opening is elongated to allow the lysing member to pivot within the first opening as the lysing tip is repositioned between the treatment configuration and the delivery configuration.
- 66. The electrosurgical device of example 65, wherein the first opening is elongated at least substantially in a direction of an axis of the first actuation rod.
- 67. The electrosurgical device of example 43, wherein at least a subset of the plurality of beads is configured to rotate about the at least one lysing member.
- 68. The electrosurgical device of example 67, wherein the at least a subset of the plurality of beads is configured to rotate in an upward direction relative to the lysing tip within a range of between about 2 degrees and about 110 degrees, and wherein the at least a subset of the plurality of beads is configured to rotate in a downward direction relative to the lysing tip within a range of between about 2 degrees and about 110 degrees.
- 69. The electrosurgical device of example 67, wherein each of the plurality of beads is configured to be independently rotatable about the at least one lysing member with respect to the other beads of the plurality of beads.
- 70. The electrosurgical device of example 64, wherein the first opening comprises internal beveling adjacent to the first opening, and wherein the internal beveling is configured to facilitate pivoting of the lysing tip between the treatment configuration and the delivery configuration.
- 71. The electrosurgical device of example 43, further comprising:
- a first coupling tip at a first end of the at least one lysing member; and
- a second coupling tip at a second end of the at least one lysing member opposite from the first end, wherein the first coupling tip and the second coupling tip are configured to secure the at least one lysing member to two outermost beads of the plurality of beads.
- 72. The electrosurgical device of example 71, wherein the first coupling tip differs from the second coupling tip.
- 73. The electrosurgical device of example 71, wherein the first coupling tip comprises a weld defining a cross-sectional dimension greater in at least one direction that a cross-sectional dimension of the at least one lysing member.
- 74. The electrosurgical device of example 43, further comprising a plurality of spacers coupled with the at least one lysing member, wherein each of the plurality of spacers is positioned between two adjacent beads of the plurality of beads.
- 75. The electrosurgical device of example 74, wherein the at least one lysing member comprises a single lysing rod.
- 76. The electrosurgical device of example 75, wherein the single lysing rod comprises a circular shape in cross section.
- 77. The electrosurgical device of example 75, wherein each of the plurality of spacers comprises an opening configured to receive a portion of the single lysing rod therethrough.
- 78. The electrosurgical device of example 77, wherein the single lysing rod has a cross-sectional shape that differs from a cross-sectional shape of an exterior surface of each of the plurality of spacers.
- 79. The electrosurgical device of example 74, wherein each of the plurality of spacers comprises a leading edge for delivery of electrosurgical energy from the at least one lysing member.
- 80. The electrosurgical device of example 79, wherein each of the plurality of spacers comprises only a single edge.
- 81. The electrosurgical device of example 80, wherein, other than the single edge, each of the plurality of spacers comprises an at least substantially smooth exterior surface such that at least substantially all of the electrosurgical energy from the at least one lysing member is delivered through the single edge.
- 82. The electrosurgical device of example 74, wherein each of the plurality of spacers comprises a conductive material such that electrosurgical energy from the at least one lysing member can be delivered through the spacers.
- 83. The electrosurgical device of example 74, wherein each of the plurality of spacers comprises an insulating material, and wherein each of the plurality of spacers comprises one or more openings configured to allow for delivery of electrosurgical energy through the one or more openings.
- 84. The electrosurgical device of example 74, wherein the at least one lysing member comprises a lysing rod having a circular cross-sectional shape, and wherein each of the plurality of spacers is crimped onto the lysing rod in between two adjacent beads of the plurality of beads.
- 85. The electrosurgical device of example 74, wherein the spacers are configured to at least substantially prevent rotation of the plurality of beads with respect to the at least one lysing member.
- 86. The electrosurgical device of example 74, wherein the spacers are configured to selectively limit an amount of rotation of the plurality of beads with respect to the at least one lysing member.
- 87. The electrosurgical device of example 43, further comprising a plurality of protuberances formed on the at least one lysing member, wherein the plurality of protuberances are configured to confine each of the plurality of beads to a predetermined region relative to the at least one lysing member.
- 88. The electrosurgical device of example 87, wherein the plurality of protuberances comprise welds formed on the at least one lysing member.
- 89. The electrosurgical device of example 43, wherein the at least one lysing member comprises a single lysing rod.
- 90. The electrosurgical device of example 89, wherein the lysing rod comprises a leading edge for delivery of electrosurgical energy.
- 91. The electrosurgical device of example 90, wherein the lysing rod comprises only a single edge.
- 92. The electrosurgical device of example 91, wherein, other than the single edge, the lysing rod comprises an at least substantially smooth exterior surface.
- 93. The electrosurgical device of example 89, wherein the lysing rod comprises a polygonal shape in cross section.
- 94. The electrosurgical device of example 93, wherein the lysing rod comprises at least one of a pentagonal and a hexagonal shape in cross section.
- 95. The electrosurgical device of example 43, wherein each of the plurality of beads comprises an identical shape.
- 96. The electrosurgical device of example 43, wherein two opposing outer beads of the plurality of beads comprise a first shape, and wherein at least one inner bead of the plurality of beads comprises a second shape that differs from the first shape.
- 97. The electrosurgical device of example 43, wherein each of at least a subset of the plurality of beads comprises a substantially ellipsoidal shape.
- 98. The electrosurgical device of example 43, wherein each of at least a subset of the plurality of beads comprises an annular bead structure.
- 99. The electrosurgical device of example 98, wherein each of the at least a subset of the plurality of beads comprises a bead hub positioned within the annular bead structure.
- 100. The electrosurgical device of example 99, wherein each of the bead hubs is configured to couple the bead with the at least one lysing member.
- 101. The electrosurgical device of example 43, wherein each of at least a subset of the plurality of beads comprises a trailing end and a leading end, wherein the trailing end comprises a rougher surface than the leading end.
- 102. An electrosurgical device, comprising:
- a lysing tip comprising a treatment side and an orientational-deployment side opposite from the treatment side, wherein the lysing tip further comprises:
- a plurality of beads; and
- at least one lysing member defining at least one lysing segment extending between each pair of adjacent beads, wherein the at least one lysing segment defines a coupling axis with the plurality of beads, and wherein the lysing tip comprises an open region lacking structure on the orientational-deployment side such that at least some of the plurality of beads protrudes from
- the treatment side and from the orientational-deployment side of the lysing tip.
- 103. An electrosurgical device, comprising:
- a lysing tip comprising a treatment side and an orientational-deployment side opposite from the treatment side, wherein the lysing tip further comprises:
- a plurality of beads;
- at least one lysing member defining at least one lysing segment extending between each pair of adjacent beads, wherein the at least one lysing segment defines a coupling axis with the plurality of beads; and
- a support member extending between a first outer bead of the plurality of beads and a second outer bead of the plurality of beads opposite from the first outer bead on the orientational-deployment side, wherein the support member is configured to facilitate coupling of the lysing tip to a surgical tool used to control the lysing tip during a surgical procedure within a patient's body.
- 104. The electrosurgical device of example 103, further comprising a grasping pad configured to engage at least one jaw of the surgical tool.
- 105. The electrosurgical device of example 104, wherein at least a portion of the grasping pad is electrically coupled to the at least one lysing member such that the grasping pad is configured to receive electrosurgical energy from the surgical tool and transfer the electrosurgical energy to the at least one lysing segment.
- 106. The electrosurgical device of example 104, wherein the grasping pad is formed on the support member.
- 107. The electrosurgical device of example 105, wherein the grasping pad comprises a hole configured to receive a projection extending from the at least one jaw of the surgical tool.
- 108. The electrosurgical device of example 107, wherein the grasping pad is coated with an insulating coating, wherein the hole is uncoated, and wherein the at least a portion of the grasping pad comprises the hole.
- 109. An electrosurgical system, comprising:
- a lysing tip comprising a treatment side and an orientational-deployment side opposite from the treatment side, wherein the lysing tip further comprises:
- a plurality of beads;
- at least one lysing member defining at least one lysing segment extending between each pair of adjacent beads, wherein the at least one lysing member defines a coupling axis with the plurality of beads; and
- a cannula configured for delivery of the lysing tip therethrough into a patient's body, wherein the cannula comprises a cannula axis, and wherein the system is configured such that the lysing tip can be delivered through the cannula with the coupling axis aligned with the cannula axis.
- 110. The electrosurgical system of example 109, further comprising a second cannula, wherein the second cannula comprises a lumen having a smaller cross-sectional dimension that the cannula such that the second cannula can fit within the cannula, and wherein the lysing tip is configured such that the plurality of beads is unable to be fully received within the second cannula with the coupling axis aligned with the cannula axis.
- 111. An electrosurgical system, comprising:
- a lysing tip comprising a treatment side and an orientational-deployment side opposite from the treatment side, wherein the lysing tip further comprises:
- a plurality of beads;
- at least one lysing member defining at least one lysing segment extending between each pair of adjacent beads, wherein the lysing tip comprises a primary axis extending between a first outer bead of the plurality of beads and a second outer bead of the plurality of beads, and wherein each of the plurality of beads comprises a tip extending at least substantially perpendicular to the primary axis; and
- a cannula configured for delivery of the lysing tip therethrough into a patient's body, wherein the cannula comprises a cannula axis, and wherein the system is configured such that the lysing tip can be delivered through the cannula with the primary axis aligned with the cannula axis.
- 112. An electrosurgical system, comprising:
- a lysing tip comprising a treatment side and a grasping pad opposite from the treatment side, wherein the treatment side is configured to receive and deliver electrosurgical energy for tissue one or both of dissection and modification; and
- a first instrument configured to selectively couple with the lysing tip, wherein the first instrument is configured to deliver electrosurgical energy to the treatment side of the lysing tip while the lysing tip is coupled with the first instrument, and wherein the first instrument is configured to selectively couple with the lysing tip at the grasping pad.
- 113. The electrosurgical system of example 112, wherein the lysing tip comprises:
- a plurality of protrusions;
- at least one lysing member defining at least one lysing segment between each pair of adjacent protrusions of the plurality of protrusions.
- 114. The electrosurgical system of example 112, wherein the lysing tip further comprises:
- a plurality of beads; and
- a lysing rod extending at least partially through each of the plurality of beads so as to define a plurality of lysing segments extending between adjacent beads of the plurality of beads.
- 115. The electrosurgical system of example 114, wherein the lysing tip further comprises a support member coupled to the lysing rod at opposite ends of the support member.
- 116. The electrosurgical system of example 115, wherein the lysing tip further comprises a grasping pad formed on the support member, and wherein the first instrument comprises at least one jaw configured to engage the grasping pad.
- 117. The electrosurgical system of example 116, wherein the at least one jaw comprises an upper jaw and a lower jaw, and wherein at least one of the upper jaw and the lower jaw is movable such that the upper jaw and the lower jaw are configured to open to receive the grasping pad and to close to fixedly couple the grasping pad in between the upper jaw and the lower jaw.
- 118. The electrosurgical system of example 116, wherein the at least one jaw comprises a projection, wherein the grasping pad comprises an opening configured to receive the projection.
- 119. The electrosurgical system of example 118, wherein the first instrument is configured to deliver electrosurgical energy from the projection, through the opening, and into the lysing rod.
- 120. The electrosurgical system of example 119, wherein the grasping pad comprises a non-conductive insulation, and wherein the at least one jaw comprises a non-conductive insulation.
- 121. The electrosurgical system of example 120, wherein the projection lacks the non-conductive insulation, and wherein the opening lacks the non-conductive insulation.
- 122. The electrosurgical system of example 120, wherein the non-conductive insulation comprises a coating.
- 123. The electrosurgical system of example 113, wherein the plurality of protrusions comprises a plurality of beads positioned along the at least one lysing member.
- 124. The electrosurgical system of example 114, wherein each of the plurality of beads is independently movable at least one of laterally and rotationally with respect to the at least one lysing member.
- 125. The electrosurgical system of example 114, wherein at least a subset of the plurality of beads protrudes both distally in a direction of the treatment side and proximally in a direction opposite of the direction of the treatment side relative to the at least one lysing member.
- 126. The electrosurgical system of example 114, wherein each of the plurality of beads protrudes both distally in a direction of the treatment side and proximally in a direction opposite of the direction of the treatment side relative to the at least one lysing member.
- 127. The electrosurgical system of example 112, wherein the first instrument comprises a jaw configured to receive the grasping pad of the lysing tip to couple the lysing tip to the first instrument.
- 128. The electrosurgical system of example 127, wherein the grasping pad comprises a magnet, and wherein the jaw comprises a magnetic element configured to engage the magnet.
- 129. The electrosurgical system of example 127, wherein the jaw comprises an insulated exterior surface, and wherein at least a portion of an interior surface of the jaw configured to engage the grasping pad is uninsulated to allow for delivery of electrosurgical energy through the jaw to the grasping pad and to the treatment side of the lysing tip.
- 130. The electrosurgical system of example 127, wherein the jaw is configured to open to facilitate receiving the grasping pad, and wherein the jaw is configured to close to grasp the grasping pad.
- 131. The electrosurgical system of example 127, wherein the jaw comprises a projection, wherein the grasping pad comprises a hole, and wherein the projection is configured to be received in the hole to facilitate a more stable coupling of the lysing tip with the first instrument.
- 132. The electrosurgical system of example 131, wherein the jaw is insulated, and wherein the projection is uninsulated to allow for delivery of electrosurgical energy through the projection to the grasping pad and to the treatment side of the lysing tip.
- 133. The electrosurgical system of example 112, further comprising a second instrument configured to facilitate coupling of the lysing tip to the first instrument.
- 134. The electrosurgical system of example 133, further comprising:
- a first cannula configured to deliver the first instrument and the lysing tip into a patient's body; and
- a second cannula configured to deliver the second instrument into the patient's body.
- 135. The electrosurgical system of example 133, wherein the second instrument lacks the ability to deliver electrosurgical energy.
- 136. The electrosurgical system of example 133, wherein the first instrument comprises a jaw, wherein the second instrument comprises a jaw, and wherein the jaw of the first instrument is identical to the jaw of the second instrument.
- 137. The electrosurgical system of example 112, further comprising a first cannula configured to deliver the first instrument and the lysing tip into a patient's body.
- 138. The electrosurgical system of example 112, further comprising a linking member positioned opposite from the treatment side, wherein the linking member is configured to facilitate coupling of the lysing tip with the first instrument.
- 139. The electrosurgical system of example 138, wherein the grasping pad extends from the linking member.
- 140. The electrosurgical system of example 112, wherein the first instrument comprises at least one of means for grasping the lysing tip and means for controlling the lysing tip during a surgical procedure.
- 141. The electrosurgical system of example 140, wherein the first instrument comprises means for grasping the lysing tip, and wherein the means for grasping the lysing tip comprises a pair of jaws configured to receive the grasping pad.
- 142. The electrosurgical system of example 141, wherein at least one jaw of the pair of jaws is movable.
- 143. The electrosurgical system of example 112, further comprising a tether coupled with the lysing tip, wherein the tether is configured to facilitate coupling of the lysing tip with the first instrument.
- 144. The electrosurgical system of example 143, wherein the tether is coupled with the grasping pad of the lysing tip.
- 145. The electrosurgical system of example 144, wherein the first instrument comprises a jaw configured to receive the grasping pad of the lysing tip to couple the lysing tip to the first instrument, and wherein the tether extends through an opening formed in the jaw.
- 146. The electrosurgical system of example 143, wherein the tether is configured to, upon being retracted, direct the lysing tip into an engagement feature of the first instrument.
- 147. The electrosurgical system of example 146, wherein the engagement feature comprises a jaw.
- 148. The electrosurgical system of example 112, wherein the first instrument comprises at least one jaw, wherein the at least one jaw is configured to engage the grasping pad of the lysing tip, and wherein the system is configured such that the first instrument delivers electrosurgical energy from the at least one jaw, through the grasping pad, and into a plurality of lysing segments on the treatment side.
- 149. The electrosurgical system of example 148, further comprising a slot formed in the at least one jaw, wherein the slot is configured to receive at least a portion of the grasping pad.
- 150. The electrosurgical system of example 149, wherein the at least one jaw is configured to open and shut, and wherein the slot is configured to enclose the grasping pad about at least 3 sides of the grasping pad and at least partially about a fourth side of the grasping pad when the at least one jaw is closed with the grasping pad positioned therein.
- 151. The electrosurgical system of example 149, wherein the at least one jaw comprises at least one of an insulating cover and an insulating coating, and wherein at least a portion of the slot lacks the at least one of an insulating cover and an insulating coating so as to allow for transfer of electrosurgical energy therethrough.
- 152. A method for use of an electrosurgical device, the method comprising the steps of:
- delivering a lysing tip through a first cannula into a patient's body;
- advancing the lysing tip beyond a distal opening of the first cannula;
- delivering a first instrument through a second cannula into the patient's body adjacent to the lysing tip;
- coupling the lysing tip with the first instrument;
- advancing a second instrument through the first cannula into the patient's body such that at least a distal end of the second instrument protrudes beyond the distal opening of the first cannula;
- using the first instrument to couple the lysing tip with the second instrument;
- releasing the lysing tip from the first instrument; and
- using the second instrument to perform a surgical procedure with the lysing tip.
- 153. The method of example 152, wherein the second instrument comprises at least one jaw configured to engage a first portion of the lysing tip, and wherein the step of using the first instrument to couple the lysing tip with the second instrument comprises advancing the first portion of the lysing tip into the at least one jaw.
- 154. The method of example 153, wherein the step of using the first instrument to couple the lysing tip with the second instrument further comprises closing the at least one jaw to secure the first portion of the lysing tip therein.
- 155. The method of example 153, wherein the first portion of the lysing tip comprises a grasping pad protruding from a proximal side of the lysing tip.
- 156. The method of example 155, wherein lysing tip comprises an energy delivery side opposite from the proximal side, and wherein the second instrument is configured to deliver electrosurgical energy through the grasping pad to the energy delivery side when the second instrument is coupled with the lysing tip.
- 157. The method of example 153, wherein the first instrument comprises at least one jaw configured to engage a second portion of the lysing tip distinct from the first portion.
- 158. The method of example 148, wherein the step of advancing the lysing tip beyond a distal opening of the first cannula is performed using the second instrument.
- 159. The method of example 148, wherein the second instrument is configured to deliver electrosurgical energy to the lysing tip when the second instrument is coupled with the lysing tip.
- 160. The method of example 159, wherein the first instrument lacks the ability to deliver electrosurgical energy.
- 161. An electrosurgical system, comprising:
- a lysing tip comprising a treatment side and an orientational-deployment side opposite from the treatment side, wherein the lysing tip further comprises:
- a plurality of beads, wherein each of the plurality of beads extends from the treatment side towards the orientational-deployment side, and wherein the plurality of beads collectively defines a lysing tip axis extending between two outer beads of the plurality of beads; and
- at least one lysing member defining at least one lysing segment extending between each pair of adjacent beads, wherein the at least one lysing member defines a coupling axis with the plurality of beads;
- a cannula comprising a lumen configured to deliver the lysing tip therethrough; and
- at least one actuation rod coupled with the lysing tip, wherein the at least one actuation rod is configured to reorient the lysing tip between a delivery configuration in which the lysing tip axis extends through the lumen and a treatment configuration in which the lysing tip axis extends at least substantially perpendicular to an axis of the lumen outside of a distal end of the cannula.
- 162. The system of example 161, wherein the lysing tip comprises an open region lacking structure on the orientational-deployment side proximal to the at least one lysing member and the plurality of beads.
- 163. The system of example 161, wherein the lysing tip is configured such that at least a subset of the plurality of beads protrude from the treatment side and at least a subset of the plurality of beads protrude from the orientational-deployment side.
- 164. The system of example 161, wherein the at least one lysing member comprises a lysing plate, and wherein the lysing plate extends along the lysing tip axis.
- 165. The system of example 164, wherein the lysing tip is configured such that the lysing plate extends through each of the plurality of beads, and such that the lysing plate alone supports each of the plurality of beads on the lysing tip.
- 166. The system of example 161, wherein the electrosurgical system is configured such that the lysing tip axis extends at least substantially parallel to the axis of the lumen in the delivery configuration.
- 167. The system of example 161, wherein the electrosurgical system is configured such that at least one of the two outer beads of the plurality of beads extends beyond a cross-sectional profile of an opening at the distal end of the cannula in the treatment configuration.
- 168. The system of example 167, where the electrosurgical system is configured such that both of the two outer beads of the plurality of beads extends beyond a cross-sectional profile of an opening at the distal end of the cannula in the treatment configuration.
- 169. The system of example 161, further comprising a second cannula, wherein the second cannula comprises a lumen having a smaller cross-sectional size than the cannula, and wherein the second cannula is configured to be received within the cannula.
- 170. The system of example 169, wherein the lysing tip is configured such that none of the plurality of beads is configured to be fully received within the second cannula in either the delivery or treatment configurations.
- 171. The system of example 161, wherein the at least one actuation rod comprises a first actuation rod and a second actuation rod.
- 172. The system of example 171, wherein the first actuation rod comprises a distal portion coupled to the lysing tip, wherein the distal portion extends at least substantially parallel to the lysing tip axis.
- 173. The system of example 172, wherein the distal portion extends at least substantially perpendicular to a proximal portion of the first actuation rod.
- 174. The system of example 173, wherein the at least one lysing member comprises a lysing plate, and wherein the distal portion is coupled directly to the lysing plate.
- 175. The system of example 174, wherein the distal portion is pivotably coupled to the lysing plate.
- 176. The system of example 175, further comprising a pivot member for coupling the lysing plate to the first actuation rod.
- 177. The system of example 161, further comprising a horizontal tunnel extending through each of the plurality of beads, wherein the at least one lysing member is positioned to extend at least partially through the horizontal tunnel.
- 178. The system of example 177, wherein the at least one lysing member comprises a lysing plate, and wherein the lysing plate extends through the horizontal tunnel to define a plurality of lysing segments between each pair of adjacent beads.
- 179. The system of example 177, wherein each of the plurality of beads comprises a vertical tunnel extending between an upper end of the bead and a lower end of the bead.
- 180. The system of example 179, further comprising a plurality of pins, wherein each of the plurality of pins extends through one of the vertical tunnels, and wherein each of the plurality of pins also extends through an opening formed in the lysing plate to secure the plurality of beads to the lysing plate.
- 181. The system of example 161, wherein the at least one actuation rod comprises a hinge structure.
- 182. The system of example 179, wherein the hinge structure is configured to allow the lysing tip to be rotated at least one of above and below a cross-sectional profile of an opening at the distal end of the cannula in the treatment configuration.
- 183. The system of example 182, wherein the at least one actuation rod comprises a first actuation rod and a second actuation rod, wherein the first actuation rod comprises a first hinge structure, and wherein the second actuation rod comprises a second hinge structure.
- 184. The system of example 183, wherein both the first and second hinge structures are configured to allow the lysing tip to be rotated either above or below the cross-sectional profile of the opening at the distal end of the cannula in the treatment configuration.
- 185. The system of example 161, further comprising a second cannula, wherein the second cannula comprises a lumen having a smaller cross-sectional size than the cannula, wherein the second cannula is configured to be received within the cannula, and wherein the lysing tip is configured such that the plurality of beads is configured to be fully received within the cannula and the second cannula in the delivery configuration.
- 186. The system of example 161, wherein the lysing tip further comprises a support member coupled to the at least one lysing member and extending along the orientational-deployment side of the lysing tip, wherein the support member is configured to facilitate coupling of the lysing tip with the at least one actuation rod.
- 187. The system of example 186, wherein the support member is coupled to the at least one lysing member adjacent to the two outer beads.
- 188. The system of example 187, wherein the support member is coupled to the at least one lysing member adjacent to respective inner surfaces of the two outer beads.
- 189. The system of example 186, wherein the support member is formed in a bow shape from a first end of the support member coupled with the at least one lysing member to a second end of the support member coupled with the at least one lysing member opposite from the first end.
- 190. The system of example 189, wherein the at least one actuation rod comprises a first actuation rod and a second actuation rod, wherein the support member comprises a first hole configured to receive a first coupling member for coupling the first actuation rod to the support member, and wherein the support member further comprises a second hole configured to receive a second coupling member for coupling the second actuation rod to the support member.
- 191. The system of example 190, wherein the first coupling member comprises a pin, and wherein the second coupling member comprises a pin.
- 192. The system of example 190, wherein the first hole is offset from the second hole with respect to at least one central axis of the lysing tip.
- 193. The system of example 192, wherein the first hole is offset from the second hole with respect to at least one of a central axis defined by the at least one lysing member and a central axis of the lysing tip extending between the treatment side and the orientational-deployment side of the lysing tip.
- 194. The system of example 193, wherein the first hole is positioned a first distance from the at least one lysing member, wherein the second hole is positioned a second distance from the at least one lysing member, and wherein the first distance differs from the second distance.
- 195. The system of example 186, wherein the at least one actuation rod comprises a first actuation rod and a second actuation rod, wherein the support member comprises a first hole configured to receive a first pin for coupling the first actuation rod to the support member, and wherein the support member further comprises a second hole configured to receive a second pin for coupling the second actuation rod to the support member.
- 196. The system of example 195, wherein the support member is formed with a first knob protruding from the support member, and wherein the first hole is formed in the first knob.
- 197. The system of example 196, wherein the support member is formed with a second knob protruding from the support member, and wherein the second hole is formed in the second knob.
- 198. The system of example 197, wherein the support member is formed in a bow shape from a first end of the support member coupled with the at least one lysing member to a second end of the support member coupled with the at least one lysing member opposite from the first end.
- 199. The system of example 161, wherein the at least one actuation rod comprises a lysing tip receptacle configured to at least partially receive the lysing tip when the lysing tip is repositioned from the treatment configuration to the delivery configuration.
- 200. The system of example 199, wherein the lysing tip further comprises a support member coupled to the at least one lysing member and extending along the orientational-deployment side of the lysing tip, wherein the support member is configured to facilitate coupling of the lysing tip with the at least one actuation rod, and wherein the lysing tip receptacle is configured to receive the support member.
- 201. The system of example 199, wherein the at least one actuation rod comprises a first actuation rod and a second actuation rod, and wherein the lysing tip receptacle comprises a cutout region formed in the first actuation rod.
- 202. The system of example 161, wherein the at least one actuation rod comprises a first actuation rod and a second actuation rod, wherein the first actuation rod comprises a distal portion and a proximal portion, wherein the second actuation rod comprises a distal portion and a proximal portion, and wherein the distal portions of the first and second actuation rods are configured to pivot with respect to the proximal portions of the first and second actuation rods.
- 203. The system of example 202, wherein the first actuation rod comprises a first hinge member configured to pivot the proximal portion of the first actuation rod with respect to the distal portion of the first actuation rod, wherein the second actuation rod comprises an opening configured to at least partially receive the first hinge member while the lysing tip is in the delivery configuration.
- 204. The system of example 203, wherein the first actuation rod further comprises a lysing tip receptacle configured to at least partially receive the lysing tip when the lysing tip is repositioned from the treatment configuration to the delivery configuration.
- 205. The system of example 161, wherein the lysing tip and the cannula are configured such that the lysing tip may be fully received within the cannula in the delivery configuration.
- 206. The system of example 205, wherein the electrosurgical system is configured such that the lysing tip axis extends at an angle with respect to the axis of the lumen of the cannula in the delivery configuration.
- 207. The system of example 161, wherein the at least one lysing member comprises a single lysing member, wherein the single lysing member defines a plurality of lysing segments, and wherein each lysing segment extends between an adjacent pair of beads of the plurality of beads.
- 208. The system of example 207, further comprising a plurality of spacers, wherein each spacer of the plurality of spacers is coupled with a lysing segment of the plurality of lysing segments.
- 209. The system of example 208, wherein each of the plurality of spacers is configured to confine each of the plurality of beads to a predetermined region relative to the single lysing member.
- 210. The system of example 207, further comprising a plurality of protuberances coupled with the single lysing member, wherein each of the plurality of lysing segments comprises a first protuberance at a first end of the lysing segment and a second protuberance at a second end of the lysing segment.
- 211. The system of example 207, wherein the single lysing member comprises a non-circular shape in cross section along at least a portion of the single lysing member.
- 212. The system of example 211, wherein the single lysing member comprises a non-circular shape in cross section only at locations corresponding with each of the plurality of beads.
- 213. The system of example 211, wherein the single lysing member comprises a non-circular shape in cross section along an entire length of the single lysing member.
- 214. The system of example 161, wherein each of the plurality of beads has an at least substantially identical length extending between the treatment side and the orientational-deployment side.
- 215. The system of example 161, wherein the at least one actuation rod comprises a first actuation rod and a second actuation rod, wherein at least one of the first actuation rod and the second actuation rod comprises a retraction guide configured to facilitate repositioning of the lysing tip between the treatment configuration and the delivery configuration.
- 216. The system of example 215, wherein the retraction guide is configured to provide a restorative force to the lysing tip by contacting the cannula when the lysing tip is repositioned from the treatment configuration to the delivery configuration.
- 217. The system of example 216, wherein the retraction guide comprises a spring positioned on the first actuation rod.
- 218. The system of example 216, wherein the retraction guide extends from the first actuation rod by a first distance, wherein at least one bead of the plurality of beads extends from the first actuation rod in the delivery configuration by a second distance, and wherein the first distance is at least one of approximately equal to and slightly greater than the second distance.
- 219. The system of example 218, wherein the first distance is between about 1% and about 10% greater than the second distance.
- 220. The system of example 161, further comprising a protective sleeve configured to encase the lysing tip during delivery.
- 221. The system of example 220, wherein the protective sleeve is removable such that the protective sleeve may be removed prior to treatment using the lysing tip.
- 222. The system of example 220, wherein the protective sleeve is made up of a biodegradable material.
- 223. The system of example 161, wherein the lysing tip further comprises an antenna configured to track a location of the lysing tip during a surgical procedure.
- 224. The system of example 223, wherein the antenna comprises a radiofrequency identification tag.
- 225. The system of example 223, wherein the lysing tip further comprises a sensor, and wherein the sensor is coupled with the antenna such that location data may be combined with sensor data from the sensor.
- 226. The system of example 225, wherein the sensor comprises a temperature sensor.
- 227. The system of example 161, further comprising a canal configured to selectively deliver fluids adjacent to the lysing tip during a surgical procedure.
- 228. The system of example 227, wherein the canal is selectively retractable and advanceable relative to the cannula.
- 229. The system of example 161, wherein the at least one lysing member comprises a first lysing member and a second lysing member, and wherein the first lysing member is electrically isolated from the second lysing member.
- 230. The system of example 229, wherein the lysing tip is configured to deliver bipolar electrosurgical energy, wherein the first lysing member comprises a positive lysing member configured to deliver positive electrosurgical energy, and wherein the second lysing member comprises a negative lysing member configured to deliver negative electrosurgical energy.
- 231. The system of example 229, wherein the first lysing member defines only a first lysing segment of the plurality of lysing segments, and wherein the second lysing member defines only a second lysing segment of the plurality of lysing segments.
- 232. The system of example 229, further comprising:
- a first tunnel formed in at least a first subset of the plurality of beads; and
- a second tunnel formed in at least a second subset of the plurality of beads, wherein the first lysing member extends through the first tunnel, and wherein the second lysing member extends through the second tunnel.
- 233. The system of example 232, wherein the first lysing member comprises a flexible wire and wherein the second lysing member comprises a flexible wire.
- 234. The system of example 233, further comprising means for maintaining a flexible lysing member in a rigid state to define a lysing segment.
- 235. The system of example 234, wherein the means for maintaining a flexible lysing member in a rigid state to define a lysing segment comprises at least one of a bead tunnel having a cross-sectional dimension less than a cross-sectional dimension of a lysing member extending therethrough and a plurality of protuberances.
- 236. An electrosurgical system, comprising:
- a lysing tip comprising a treatment side and an orientational-deployment side opposite from the treatment side, wherein the lysing tip comprises an upper side and a lower side opposite from the upper side, and wherein the lysing tip further comprises:
- a plurality of beads;
- at least one lysing member defining at least one lysing segment extending between each pair of adjacent beads, wherein the lysing tip comprises a primary axis extending between a first outer bead of the plurality of beads and a second outer bead of the plurality of beads, and wherein each of the plurality of beads comprises a tip extending at least substantially perpendicular to the primary axis; and
- an energy window positioned on at least one of the upper side and the lower side of the lysing tip, wherein the energy window is configured to selectively deliver energy therethrough to treat tissue during a surgical procedure with the lysing tip; and
- a cannula configured for delivery of the lysing tip therethrough into a patient's body, wherein the cannula comprises a cannula axis, and wherein the system is configured such that the lysing tip can be delivered through the cannula in a delivery configuration.
- 237. The system of example 229, wherein the system is configured such that the lysing tip can be delivered through the cannula in a delivery configuration with the primary axis aligned with the cannula axis.
- 238. The system of example 229, wherein the energy window comprises an energy window array defined by plurality of electrode termini.
- 239. The system of example 238, wherein each of the plurality of electrode termini are separated from one another such that the energy window is configured to treat tissue with the energy window to result in damaged tissue from the electrode termini and intermittent islands of undamaged tissue.
- 240. The system of example 229, further comprising a support member extending between the first outer bead of the plurality of beads and the second outer bead of the plurality of beads opposite from the first outer bead on the orientational-deployment side.
- 241. The system of example 240, further comprising a first actuation rod and a second actuation rod, wherein the first and second actuation rods are configured to reorient the lysing tip between a delivery configuration in which the primary axis extends through the lumen and a treatment configuration in which the primary axis extends at least substantially perpendicular to an axis of the lumen outside of a distal end of the cannula.
- 242. The system of example 241, wherein the first actuation rod is coupled to the support member adjacent to the first outer bead, and wherein the second actuation rod is coupled to the support member adjacent to the second outer bead.
- 243. The system of example 242, wherein the support member is formed in a bow shape from a first end of the support member to a second end of the support member opposite from the first end.
- 244. The system of example 243, wherein the support member is coupled with the at least one lysing member at the first end second end of the support member and at the second end of the support member.
- 245. The system of example 229, wherein the energy window comprises an energy window strip, and wherein the energy window strip is positioned to extend along respective upper surfaces of each of the plurality of beads.
- 246. The system of example 240, wherein the energy window strip comprises a plurality of electrode termini.
- 247. The system of example 246, wherein each of the plurality of electrode termini protrude from an upper surface of the energy window strip.
- 248. The system of example 240, further comprising an energy window cover configured to receive the energy window strip and couple the energy window strip with each of the plurality of beads.
- 249. The system of example 248, wherein the energy window cover comprises an insulation cover made up of a non-conductive material, and wherein the energy window strip is made up of a conductive material configured to receive and delivery energy therethrough.
- 250. The system of example 249, wherein the insulation cover comprises:
- an elongated base configured to receive the energy window strip; and
- a plurality of bead coupling members, wherein each of the plurality of bead coupling members is configured to couple with one of the plurality of beads.
- 251. The system of example 240, wherein the energy window strip is configured to deliver at least one of LASER, intense pulse light, resistive heating, radiant heat, ultrasound, and microwave energy.
- 252. The system of example 240, wherein the energy window strip is configured to deliver radiofrequency energy.
- 253. The system of example 238, wherein the energy window is configured to deliver bipolar electrosurgical energy, and wherein a first subset of the plurality of electrode termini are electrically isolated from a second subset of the plurality of electrode termini.
- 254. A method for delivery of an electrosurgical device into a patient for use during a surgical procedure, the method comprising the steps of:
- delivering a lysing tip through a first cannula subcutaneously into a patient's body, wherein the lysing tip comprises:
- a plurality of beads;
- at least one lysing member defining at least one lysing segment extending between each pair of adjacent beads; and
- a support member coupled with the at least one lysing member, wherein the support member is configured to facilitate coupling of the lysing tip to a surgical tool used to control the lysing tip during a surgical procedure within the patient's body;
- advancing the lysing tip beyond a distal opening of the first cannula;
- delivering the surgical tool into the patient's body adjacent to the lysing tip;
- coupling the lysing tip with the surgical tool; and
- delivering electrosurgical energy from the surgical tool to the at least one lysing member.
- 255. The method of example 254, wherein the support member extends between a first outer bead of the plurality of beads and a second outer bead of the plurality of beads opposite from the first outer bead on the orientational-deployment side.
- 256. The method of example 254, wherein the at least a proximal portion of the support member extends along the orientational-deployment side of the lysing tip, and wherein the step of coupling the lysing tip to the surgical tool comprises coupling the proximal portion of the support member with the surgical tool.
- 257. The method of example 256, wherein the support member defines a bow shape, wherein the support member comprises a grasping pad, wherein the surgical tool comprises at least one jaw, and wherein the step of coupling the lysing tip to the surgical tool comprises coupling the grasping pad with the at least one jaw.
- 258. The method of example 254, further comprising a tunnel extending at least partially through each of the plurality of beads, wherein the at least one lysing member is positioned to extend at least partially through the tunnel to define the at least one lysing segment between each pair of adjacent beads.
- 259. The method of example 254, wherein the step of delivering the surgical tool into the patient's body adjacent to the lysing tip comprises delivering the surgical tool through a second cannula.
- 260. The method of example 254, further comprising:
- advancing a second surgical tool into the patient's body;
- using the second surgical tool to couple the lysing tip with the first surgical tool;
- releasing the lysing tip from the second surgical tool; and
- using the first surgical tool to perform a surgical procedure with the lysing tip.
- 261. The method of example 254, wherein the lysing tip further comprises a plurality of spacers, and wherein each of the plurality of spacers is coupled with a respective lysing segment of the plurality of lysing segments.
- 262. A lysing tip, comprising:
- a treatment side and an orientational-deployment side opposite from the treatment side;
- a grasping pad on the orientational-deployment side, wherein the grasping pad is configured to receive and deliver electrosurgical energy;
- a plurality of beads;
- a lysing rod defining a plurality of lysing segments, wherein each of the plurality of lysing segments extends between a pair of adjacent beads of the plurality of beads; and
- a support member coupled to the lysing rod at opposite ends of the lysing rod, wherein the support member is configured to facilitate coupling of the lysing tip to a surgical tool used to control the lysing tip during a surgical procedure within a patient's body and deliver electrosurgical energy through the grasping pad and into the lysing rod.
- 263. The lysing tip of example 262, wherein the grasping pad is formed on the support member.
- 264. The lysing tip of example 263, wherein the grasping pad comprises a tab projecting from the support member.
- 265. The lysing tip of example 262, wherein the support member is coupled to the lysing rod between a first outer bead of the plurality of beads and a second outer bead of the plurality of beads opposite from the first outer bead on the orientational-deployment side.
- 266. The lysing tip of example 265, wherein the support member is formed in a bow shape from a first end of the support member coupled with the lysing rod to a second end of the support member coupled with the lysing rod opposite from the first end.
- 267. The lysing tip of example 262, further comprising a plurality of spacers, wherein each of the plurality of spacers is coupled with the lysing rod at a respective lysing segment of the plurality of lysing segments.
- 268. The lysing tip of example 267, wherein each of the plurality of spacers is fixedly coupled with the lysing rod.
- 269. The lysing tip of example 267, wherein each of the plurality of spacers comprises a slot configured to allow each of the respective spacers to be coupled with the lysing rod by advancing each of the respective spacers towards the lysing rod adjacent to the slot in a direction perpendicular to an axis of the lysing rod.
- 270. The lysing tip of example 267, wherein each of the plurality of spacers comprises a conductive material such that electrosurgical energy can be delivered through the spacers from the lysing rod.
- 271. The lysing tip of example 267, wherein each of the plurality of spacers is configured to confine at least one respective bead of the plurality of beads to a predetermined location on the lysing rod.
- 272. The lysing tip of example 271, wherein each of the plurality of spacers is configured to restrict an amount of rotation of at least one respective bead of the plurality of beads on the lysing rod.
- 273. The lysing tip of example 272, wherein each of the plurality of spacers comprises opposing beveled edges configured to selectively restrict rotation of adjacent beads on the lysing rod.
- 274. The lysing tip of example 271, wherein each of the plurality of spacers is in direct contact with two respective beads on opposite ends of the spacer.
- 275. The lysing tip of example 262, further comprising a plurality of protuberances configured to confine each of the plurality of beads to a predetermined region relative to the lysing rod, wherein each of the lysing segments comprises a first protuberance adjacent a first respective bead and a second protuberance adjacent a second respective beads.
- 276. The lysing tip of example 273, wherein the plurality of protuberances are configured to prevent any lateral movement of the plurality of beads on the lysing rod.
- 277. The lysing tip of example 262, wherein the lysing rod comprises a hollow rod.
- 278. The lysing tip of example 277, wherein the lysing rod comprises a first plurality of sections having non-circular cross-sections.
- 279. The lysing tip of example 278, wherein each of the first plurality of sections correspond with each of the plurality of lysing segments.
- 280. The lysing tip of example 278, wherein each of the plurality of sections is configured to confine each of the plurality of beads to a predetermined region relative to the lysing rod.
- 281. The lysing tip of example 278, wherein each of the plurality of sections comprises a flattened shape.
- 282. The lysing tip of example 281, wherein each of the plurality of sections comprises a leading edge extending towards the treatment side.
- 283. The lysing tip of example 278, wherein the lysing rod further comprises a second plurality of sections having circular cross-sections.
- 284. The lysing tip of example 283, wherein the second plurality of sections extend through tunnels extending at least partially through each of the plurality of beads.
- 285. The lysing tip of example 262, wherein the lysing rod extends at least partially through each of the plurality of beads.
- 286. The lysing tip of example 285, wherein the lysing rod defines a coupling axis with the plurality of beads, wherein each of the plurality of beads defines a bead axis extending from a leading end to a trailing end, and wherein the bead axis of each of the plurality of beads is at least substantially perpendicular to the coupling axis.
- 287. The lysing tip of example 286, wherein the lysing rod extends through at least a subset of the plurality of beads at a non-central location relative to a bead axis of each of the at least a subset of the plurality of beads.
- 288. The lysing tip of example 287, wherein the lysing rod extends through each of the plurality of beads at a non-central location relative to a bead axis of each of the plurality of beads.
- 289. The lysing tip of example 287, wherein the non-central location is positioned towards the leading end of each of the at least a subset of the plurality of beads.
- 290. The lysing tip of example 262, wherein each of the plurality of beads defines a bead axis extending from a leading end to a trailing end, wherein the plurality of beads comprises a first subset of beads having a first length extending along the bead axis of each of the first subset of beads, wherein the plurality of beads comprises a second subset of beads having a second length extending along the bead axis of each of the second subset of beads, and wherein the first length is greater than the second length.
- 291. The lysing tip of example 290, wherein the first subset of beads comprises a first outer bead positioned adjacent to a first end of the lysing rod and a second outer bead positioned adjacent to a second end of the lysing rod opposite from the first end.
- 292. The lysing tip of example 291, wherein each of the second subset of beads comprises a flattened trailing end, and wherein the flattened trailing end is positioned adjacent to the support member so as to accommodate the support member extending proximally of the trailing ends of each of the second subset of beads.
- 293. The lysing tip of example 292, wherein the support member comprises an insulated portion and a conductive portion.
- 294. The lysing tip of example 293, wherein the conductive portion comprises at least a portion of a grasping pad formed on the support member.
- 295. The lysing tip of example 294, wherein the conductive portion comprises an opening formed on the grasping pad.
- 296. The lysing tip of example 262, wherein each of at least a subset of the plurality of beads is configured so as to allow for rotation of each respective bead of the at least a subset of the plurality of beads about the lysing rod.
- 297. The lysing tip of example 296, wherein each of the plurality of beads is configured so as to allow for rotation of each respective bead of the plurality of beads about the lysing rod.
- 298. The lysing tip of example 262, wherein each of at least a subset of the plurality of beads comprises a trailing end having a rougher exterior surface that its respective leading end.
- 299. The lysing tip of example 298, wherein the at least a subset of the plurality of beads comprises a first outer bead positioned at a first end of the lysing rod and a second outer bead positioned at a second end of the lysing rod opposite from the first end.
- 300. The lysing tip of example 299, wherein the first outer bead is positioned adjacent to a first end of the lysing rod, and wherein the second outer bead is positioned adjacent to a second end of the lysing rod opposite from the first end of the lysing rod.
- 301. The lysing tip of example 262, wherein each of at least a subset of the plurality of beads comprises a plurality of faceted surfaces.
- 302. The lysing tip of example 301, wherein each of at least a subset of the plurality of faceted surfaces is positioned at an acute angle with respect to one another.
- 303. The lysing tip of example 302, each of at least a subset of the plurality of beads comprises a first faceted surface on an upper side of the bead and a second faceted surface on a lower side of the bead, wherein the first faceted surface and the second faceted surface defined a wedge shape at a leading end of the bead.
- 304. The lysing tip of example 262, wherein each of at least a subset of the plurality of beads is configured to move with respect to the lysing rod during a surgical procedure.
- 305. The lysing tip of example 304, wherein each of the at least a subset of the plurality of beads is configured to pivot on the lysing rod.
- 306. The lysing tip of example 305, wherein each of the at least a subset of the plurality of beads is configured to pivot on the lysing rod in at least two separate planes.
- 307. The lysing tip of example 262, wherein at least one of the plurality of beads comprises a hole separated from the lysing rod, and wherein the hole is configured to be coupled with means for maintaining retrievability of a free-floating lysing tip when the lysing tip is decoupled from a grasping/control instrument.
- 308. The lysing tip of example 262, wherein the means for maintaining retrievability of a free-floating lysing tip when the lysing tip is decoupled from a grasping/control instrument comprises a cord.
- 309. The lysing tip of example 262, further comprising:
- a first coupling tip at a first end of the lysing rod; and
- a second coupling tip at a second end of the lysing rod, wherein the first coupling tip and the second coupling tip are configured to secure the lysing rod to two outermost beads of the plurality of beads.
- 310. The lysing tip of example 309, wherein the first coupling tip differs from the second coupling tip.
- 311. The lysing tip of example 309, wherein the first coupling tip comprises a weld defining a cross-sectional dimension greater in at least one direction that a cross-sectional dimension of the lysing rod.
- 312. The lysing tip of example 262, wherein the lysing rod comprises at least one of a non-conductive coating and a non-conductive cover positioned at opposing ends of the lysing rod.
- 313. The lysing tip of example 312, further comprising:
- a first coupling tip at a first end of the lysing rod; and
- a second coupling tip at a second end of the lysing rod, wherein the first coupling tip and the second coupling tip are configured to secure the lysing rod to two outermost beads of the plurality of beads, and wherein the first coupling tip and the second coupling tip both comprise at least one of a non-conductive coating and a non-conductive cover.
- 314. The lysing tip of example 262, further comprising:
- a first coupling tip at a first end of the lysing rod; and
- a second coupling tip at a second end of the lysing rod, wherein the first coupling tip and the second coupling tip are configured to secure the lysing rod to two outermost beads of the plurality of beads, wherein the first coupling tip is positioned within a first outermost bead of the plurality of beads, and wherein the second coupling tip is positioned within a second outermost bead of the plurality of beads opposite from the first outermost bead.
- 315. The lysing tip of example 314, wherein each of the first outermost bead and the second outermost bead comprises two concentric tunnels, and wherein each of the first coupling tip and the second coupling tip is positioned and configured to engage a ledge positioned at a transition point between the two concentric tunnels.
- 316. The lysing tip of example 314, wherein each of the first outermost bead and the second outermost bead comprises a tunnel that tapers from a larger dimension to a smaller dimension at an inner side of the outermost beads, and wherein each of the first coupling tip and the second coupling tip is configured to engage a portion of their respective tunnel between the larger dimension and the smaller dimension.
- 317. The lysing tip of example 262, wherein the grasping pad comprises a plate having opposing flattened surfaces configured to engage opposing jaws of the surgical tool.
- 318. The lysing tip of example 262, further comprising a non-conductive sheath configured to cover at least a portion of the lysing tip, wherein the non-conductive sheath is configured to expose the plurality of lysing segments.
- 319. An electrosurgical system, comprising:
- a lysing tip comprising:
- a plurality of beads; and
- a lysing member coupling the plurality of beads together, wherein the lysing member defines at least one lysing segment extending between each pair of adjacent beads of the plurality of beads; and
- a surgical tool configured to selectively engage the lysing tip and control the lysing tip during a surgical procedure, wherein the surgical tool comprises a pair of jaws configured to engage the lysing tip by grasping the lysing tip.
- 320. The electrosurgical system of example 319, wherein the electrosurgical system is configured such that the surgical tool is configured to selectively engage the lysing tip by grasping the lysing member.
- 321. The electrosurgical system of example 319, wherein a distal end of the surgical tool is configured to protrude distally beyond the lysing member when the lysing tip is engaged with the pair of jaws.
- 322. The electrosurgical system of example 320, wherein, when the lysing tip is engaged with the pair of jaws, the plurality of beads and the distal end of the surgical tool are configured to facilitate blunt dissection of tissue during a surgical procedure.
- 323. The electrosurgical system of example 320, wherein the distal end of the surgical tool is configured to protrude distally beyond the lysing member when the lysing tip is engaged with the pair of jaws by a distance at least substantially equal to a distance with which each of the plurality of beads protrudes distally from the lysing member.
- 324. The electrosurgical system of example 320, wherein a portion of the distal end of the surgical tool that protrudes distally beyond the lysing member when the lysing tip is engaged with the pair of jaws has a shape that is at least substantially identical to a shape of a portion of each of the plurality of beads that protrudes distally beyond the lysing member.
- 325. The electrosurgical system of example 319, wherein the lysing member comprises a lysing plate.
- 326. The electrosurgical system of example 319, further comprising a slot defined by at least one of the pair of jaws, wherein the slot is configured to receive the lysing member.
- 327. The electrosurgical system of example 326, wherein the lysing member comprises a lysing plate, and wherein the slot has a size when the pair of jaws is closed that is at least substantially identical to a size of the lysing plate that is configured to be received in the slot such that the lysing plate can be rigidly received within the slot.
- 328. The electrosurgical system of example 319, wherein the surgical tool is configured to deliver electrosurgical energy to the lysing member through the pair of jaws when the lysing tip is coupled with the surgical tool.
- 329. The electrosurgical system of example 319, wherein the lysing member comprises a lysing rod.
- 330. The electrosurgical system of example 329, wherein the lysing rod is configured to be received in a slot formed within at least one jaw of the pair of jaws.
- 331. The electrosurgical system of example 330, wherein an upper jaw of the pair of jaws comprises an overhang portion that protrudes distally of a lower jaw of the pair of jaws such that a distal end of the surgical tool is wholly defined by the upper jaw.
- 332. The electrosurgical system of example 330, wherein the lysing rod is configured to be loosely received in the slot such that the lysing tip is allowed to rotate with respect to the surgical tool.
- 333. The electrosurgical system of example 329, wherein the lysing tip is configured to be coupled with the surgical tool such that, while coupled with the lysing tip, a distal end of the surgical tool protruding distally beyond the lysing rod, has a shape that at least substantially mimics the shapes of each of the plurality of beads.
- 334. The electrosurgical system of example 329, wherein each of the plurality of beads comprises a hole extending to the lysing rod.
- 335. The electrosurgical system of example 334, wherein each of the holes of each of the plurality of beads comprises a substantially vertical tunnel extending from an upper surface of each of the plurality of beads to the lysing rod.
- 336. The electrosurgical system of example 334, wherein each of the holes of each of the plurality of beads comprises a binding material directly coupling each of the plurality of beads to the lysing rod.
- 337. The electrosurgical system of example 329, further comprising a grasping plate coupled with the lysing rod, wherein the surgical tool is configured to selectively engage the lysing tip and control the lysing tip during a surgical procedure by grasping the grasping plate.
- 338. The electrosurgical system of example 337, wherein the surgical tool comprises an upper jaw and a lower jaw defining a receiving slot, wherein the lysing plate comprises an upper surface and a lower surface, and wherein the grasping plate is configured to be received in the receiving slot such that the upper surface engages a first inner surface of the upper jaw and such that the lower surface engages a second inner surface of the lower jaw.
- 339. The electrosurgical system of example 337, wherein the lysing rod is coupled to the grasping plate such that the lysing rod fits within a groove formed in a distal surface of the grasping plate.
- 340. The electrosurgical system of example 339, wherein the lysing rod is coupled to the grasping plate by way of a snap-fit engagement between a central portion of the lysing rod and the groove.
- 341. The electrosurgical system of example 337, wherein each of the plurality of beads comprises a trailing end and a leading end, wherein the trailing end of each of the plurality of beads comprises a rougher surface than the leading end.
- 342. The electrosurgical system of example 337, wherein each of the plurality of beads is at least partially rotatable with respect to the lysing rod.
- 343. The electrosurgical system of example 342, wherein each of the plurality of beads is at least partially rotatable with respect to each other bead of the plurality of beads.
- 344. The electrosurgical system of example 337, wherein a first outer end of the lysing rod terminates within a first outer bead of the plurality of beads, and wherein a second outer end of the lysing rod terminates within a second outer bead of the plurality of beads.
- 345. The electrosurgical system of example 344, wherein the lysing rod comprises opposing coupling tips positioned on the first outer end and the second outer end.
- 346. The electrosurgical system of example 345, wherein each of the first outer bead and the second outer bead comprises an inner tunnel and an outer tunnel, and wherein the outer tunnel comprises a larger cross-sectional dimension than the inner tunnel such that each of the coupling tips is able to fit within the outer tunnel but unable to fit within the inner tunnel.
- 347. The electrosurgical system of example 337, wherein the grasping plate comprises at least one of a conductive opening and a conductive projection, wherein the surgical tool comprises at least one of a conductive opening and a conductive projection, and wherein the conductive opening or projection of the grasping plate is configured to selectively engage the conductive projection or opening of the surgical tool to allow for delivery of electrosurgical energy from the surgical tool, through the grasping plate, and into the lysing rod.
- 348. The electrosurgical system of example 347, wherein the grasping plate comprises a conductive opening, wherein the surgical tool comprises a pair of jaws comprising a conductive projection extending from one of the jaws of the pair of jaws, and wherein the grasping plate is insulated other than the conductive opening.
- 349. The electrosurgical system of example 348, wherein the grasping plate comprises a plurality of conductive openings, wherein the surgical tool comprises a plurality of conductive projections extending from one of the jaws, and wherein each of the plurality of conductive projections is configured to be received in a respective conductive opening of the plurality of conductive openings.
- 350. The electrosurgical system of example 319, wherein the plurality of beads comprises a first outer bead positioned at a first end of the lysing member and a second outer bead positioned at a second end of the lysing member opposite from the first end.
- 351. The electrosurgical system of example 350, wherein the first outer bead comprises a first rounded outer proximal corner, and wherein the second outer bead comprises a second rounded outer proximal corner positioned opposite from the first rounded outer proximal corner.
- 352. The electrosurgical system of example 351, wherein each of the first outer bead and the second outer bead comprises a flattened proximal surface.
- 353. The electrosurgical system of example 352, where each of the flattened proximal surfaces extends into a rounded o
- 354. The electrosurgical system of example 350, wherein each of the first outer bead and the second outer bead comprises an ellipsoidal shape extending from a proximal tip to a distal tip of each of the first outer bead and the second outer bead.
- 355. The electrosurgical system of example 354, wherein each of the first outer bead and the second outer bead comprises a hole, wherein the hole is configured to couple with a safety line that is configured to extend from the lysing tip within a patient's body to a location outside of the patient's body during a surgical procedure.
- 356. The electrosurgical system of example 355, wherein the safety line comprises at least one of a cord, a suture, and a hook.
- 357. The electrosurgical system of example 355, wherein the hole comprises a thru-hole, and wherein the hole is positioned in a proximal portion of each of the first outer bead and the second outer bead proximally of the lysing member.
- 358. The electrosurgical system of example 357, wherein the safety line comprises a loopable element configured to extend through the hole.
- 359. An electrosurgical system, comprising:
- a lysing tip comprising:
- a plurality of beads; and
- a lysing member coupling the plurality of beads together, wherein the lysing member defines at least one lysing segment extending between each pair of adjacent beads of the plurality of beads; and
- a surgical tool configured to selectively engage the lysing tip and deliver electrosurgical energy to the lysing member during a surgical procedure.
- 360. The electrosurgical system of example 359, wherein the lysing tip further comprises a shaft extending proximally from the lysing tip, wherein the shaft is electrically coupled with the lysing member, and wherein the surgical tool comprises a conductive slot configured to engage the shaft such that, when the shaft is engaged with the conductive slot, the surgical tool is able to deliver electrosurgical energy to the lysing member through the shaft.
- 361. The electrosurgical system of example 360, wherein the lysing tip further comprises a support member coupled with the lysing member.
- 362. The electrosurgical system of example 361, wherein the shaft is coupled with the support member.
- 363. The electrosurgical system of example 362, wherein the shaft comprises a conductive inner core, and wherein at least a portion of the shaft comprises an insulating outer shell.
- 364. The electrosurgical system of example 361, wherein the support member defines a bow shape, wherein the support member comprises a first end positioned adjacent to a first outer bead of the plurality of beads and coupled to the lysing member, and wherein the support member comprises a second end positioned adjacent to a second outer bead of the plurality of beads opposite from the first outer bead and coupled to the lysing member.
- 365. The electrosurgical system of example 359, further comprising a tether extending from the lysing tip.
- 366. The electrosurgical system of example 365, wherein the surgical tool comprises an opening configured to receive the tether so as to facilitate coupling the lysing tip to the surgical tool.
- 367. The electrosurgical system of example 366, wherein the surgical tool comprises at least one jaw configured to receive a portion of the lysing tip.
- 368. The electrosurgical system of example 367, wherein the opening is positioned in the at least one jaw.
- 369. The electrosurgical system of example 368, wherein the lysing tip further comprises a grasping pad configured to be received in the at least one jaw, wherein the tether extends from the grasping pad, and wherein the tether is configured to allow the grasping pad to be pulled into the at least one jaw by pulling the tether proximally.
- 370. The electrosurgical system of example 359, further comprising at least one magnet configured to guide the lysing tip to a coupling region of the surgical tool.
- 371. The electrosurgical system of example 370, wherein the coupling region comprises a pair of jaws formed on a distal end of the surgical tool.
- 372. The electrosurgical system of example 371, wherein the at least one magnet is positioned on at least one jaw of the pair of jaws.
- 373. The electrosurgical system of example 371, wherein the lysing tip further comprises a grasping pad configured to be received in the pair of jaws to couple the lysing tip with the surgical tool, and wherein the at least one magnet comprises a first magnet positioned on the grasping pad and a second magnet positioned on at least one jaw of the pair of jaws.
- 374. The electrosurgical system of example 359, wherein the surgical tool comprises at least one of an opening and a projection, wherein the lysing tip comprises at least one of a projection and an opening configured to mate with the at least one of an opening and a projection of the surgical tool to lock the lysing tip in place on the surgical tool during a surgical procedure.
- 375. The electrosurgical system of example 374, wherein the surgical tool comprises an upper jaw and a lower jaw, wherein the at least one of an opening and a projection extends from at least one of the upper jaw and the lower jaw, and wherein the lysing tip is configured to be received and engaged in between the upper jaw and the lower jaw during a surgical procedure.
- 376. The electrosurgical system of example 375, wherein the lysing tip comprises a support member extending adjacent to and proximal of the plurality of beads, and wherein the at least one of a projection and an opening of the lysing tip is formed on the support member.
- 377. The electrosurgical system of example 376, wherein the lysing tip comprises a first projection extending from an upper surface of the support member and a second projection extending from a lower surface of the support member, wherein the upper jaw comprises a first opening configured to receive the first projection, and wherein the lower jaw comprises a second opening configured to receive the second projection.
- 378. The electrosurgical system of example 377, wherein at least one of the first projection and the second projection is configured lock the lysing tip in place relative to the surgical tool at a preconfigured rotational orientation.
- 379. The electrosurgical system of example 378, wherein the at least one of the first projection and the second projection comprises a faceted surface, and wherein the surgical tool comprises an opening comprising a shape configured to mate with the faceted surface.
- 380. The electrosurgical system of example 378, wherein the at least one of the first projection and the second projection is configured to allow for locking the lysing tip in place relative to the surgical tool at any of a plurality of preconfigured rotational orientations.
- 381. The electrosurgical system of example 378, wherein the first projection is configured to lock the lysing tip in place relative to the surgical tool at a preconfigured rotational orientation, and wherein the second projection is configured to be received in the second opening so as to allow the lysing tip to rotate with respect to the surgical tool while the lysing tip is coupled with the surgical tool.
- 382. The electrosurgical system of example 381, wherein the upper jaw is configured to move with respect to the lower jaw such that the lysing tip can be rotated while the second projection is received within the second opening and the first projection is withdrawn from the first opening and then the upper jaw closed to insert the first projection into the first opening and lock the lysing tip at a particular rotational orientation.
- 383. A lysing tip, comprising:
- a plurality of beads comprising a first outer bead and a second outer bead opposite from the first outer bead; and
- a lysing rod extending along a treatment side of the lysing tip and extending at least partially through each of the plurality of beads to couple the plurality of beads to one another, wherein the lysing rod defines at least one lysing segment extending between each pair of adjacent beads of the plurality of beads, and wherein the lysing rod is configured such that a central portion of the lysing rod protrudes further distally from the treatment side than opposing portions of the lysing rod immediately adjacent to the first outer bead and the second outer bead.
- 384. The lysing tip of example 383, wherein the lysing rod extends in a bowed shape along the treatment side of the lysing tip.
- 385. The lysing tip of example 384, wherein the plurality of beads further comprises at least one middle bead positioned between the first outer bead and the second outer bead, and wherein the at least one middle bead protrudes distally from the treatment side to a greater extent than either the first outer bead or the second outer bead.
- 386. The lysing tip of example 384, further comprising a support member extending along a side of the lysing tip opposite from the treatment side, wherein the support member is configured to facilitate coupling of the lysing tip to a surgical tool used to control the lysing tip during a surgical procedure within a patient's body.
- 387. The lysing tip of example 386, wherein the support member extends in a bowed shape along the side of the lysing tip opposite from the treatment side, and wherein the bowed shape of the support member extends in an opposite direction relative to the bowed shape of the lysing rod.
- 388. The lysing tip of example 387, wherein the support member further comprises a tongue coupled with at least one central lysing segment of the lysing rod, wherein the tongue is configured to maintain the central portion of the lysing rod in a position protruding further distally from the treatment side than opposing portions of the lysing rod.
- 389. The lysing tip of example 388, wherein the tongue is coupled with a single lysing segment of the lysing rod.
- 390. The lysing tip of example 388, further comprising a groove formed in the tongue, wherein the at least one central lysing segment is positioned within the groove.
- 391. The lysing tip of example 388, wherein the tongue is positioned in contact with two beads on opposing sides of the tongue such that the tongue defines a length of a center lysing segment of the plurality of lysing segments.
- 392. The lysing tip of example 391, further comprising a plurality of spacers positioned on the lysing rod so as to confine each of the plurality of beads to predetermined locations on the lysing rod.
- 393. The lysing tip of example 392, wherein the center lysing segment lacks a spacer, and wherein each of the lysing segments other than the center lysing segment comprises a spacer positioned thereon.
- 394. A lysing tip, comprising:
- a plurality of beads;
- at least one lysing rod defining at least one lysing segment extending between each pair of adjacent beads;
- a tunnel extending at least partially through each of the plurality of beads, wherein the at least one lysing member is positioned to extend at least partially through the tunnel to define the at least one lysing segment between each pair of adjacent beads; and
- a plurality of sleeves positioned on the at least one lysing rod, wherein each of the plurality of sleeves is positioned within a bead of the plurality of beads in between the bead and the at least one lysing rod.
- 395. The lysing tip of example 394, wherein the plurality of sleeves comprises:
- a pair of outer bead sleeves positioned within two opposing outer beads of the plurality of beads; and
- at least one inner bead sleeve positioned within at least one inner bead positioned between the two opposing outer beads, wherein the pair of outer bead sleeves differs in structure from the at least one inner bead sleeve.
- 396. The lysing tip of example 394, wherein each of the plurality of sleeves comprises a material configured to at least partially insulate each of the plurality of beads from heat from the at least one lysing rod.
- 397. The lysing tip of example 396, wherein each of the plurality of sleeves comprises at least one of a ceramic material and a high-temperature thermoplastic.
- 398. The lysing tip of example 397, wherein each of the plurality of sleeves comprises at least one of an alumina, a carbide, a nitride, quartz silica, a silicate, an yttria, a zirconia, a thermoset plastic, and a high-performance thermoplastic.
- 399. The lysing tip of example 394, wherein at least a subset of the plurality of sleeves is configured to rotate about the at least one lysing rod such that beads coupled with each of the at least a subset of the plurality of sleeves can rotate on its respective sleeve with respect to the at least one lysing rod.
- 400. The lysing tip of example 399, wherein each of the plurality of sleeves is configured to allow each of the plurality of beads to rotate about the at least one lysing rod, and wherein each of the plurality of beads is configured to pivot with respect to the at least one lysing rod as it passes through tissue during a surgical procedure.
- 401. The lysing tip of example 394, wherein each of the plurality of sleeves comprises a raised band, and wherein each of the raised bands is configured to prevent one of the beads from moving laterally along the at least one lysing rod.
- 402. The lysing tip of example 401, wherein the plurality of sleeves comprises:
- a pair of outer bead sleeves positioned within two opposing outer beads of the plurality of beads, wherein each of the pair of outer bead sleeves comprises a raised band formed on an outer edge of the outer bead sleeve; and
- at least one inner bead sleeve positioned within at least one inner bead positioned between the two opposing outer beads, wherein each of the at least one inner bead sleeve comprises a raised band spaced apart from two opposing ends of each of the at least one inner bead sleeve.
- 403. The lysing tip of example 401, wherein the plurality of sleeves comprises a pair of outer bead sleeves positioned within two opposing outer beads of the plurality of beads, and wherein each of the pair of outer bead sleeves comprises an inner tunnel comprising an internal ledge at a transition between a smaller diameter portion of the inner tunnel and a larger diameter portion of the inner tunnel.
- 404. The lysing tip of example 394, further comprising a plurality of protuberances positioned on the at least one lysing rod, wherein each of at least a subset of the plurality of sleeves comprises a first protuberance positioned adjacent a first end of the sleeve and a second protuberance positioned adjacent a second end of the sleeve opposite from the first end so as to confine the sleeve to a predetermined location on the at least one lysing rod.
- 405. The lysing tip of example 394, further comprising at least one spacer positioned in between at least two adjacent beads of the plurality of beads, wherein the at least one spacer is configured to confine at least one sleeve of the plurality of sleeves to a predetermined location on the at least one lysing rod.
- 406. The lysing tip of example 394, wherein the at least one lysing rod comprises at least one hollow lysing rod.
- 407. The lysing tip of example 406, wherein the at least one hollow lysing rod comprises at least one flattened section extending between at least two adjacent beads of the plurality of beads.
- 408. The lysing tip of example 407, wherein the at least one flattened section comprises a leading distal edge extending at least substantially towards a treatment side of the lysing tip.
- 409. The lysing tip of example 394, wherein the plurality of sleeves comprises a pair of outer bead sleeves positioned within two opposing outer beads of the plurality of beads, wherein each of the pair of outer bead sleeves comprises an inner tunnel configured to receive the at least one lysing rod, and wherein the inner tunnel of each of the outer bead sleeves comprises a taper from a larger diameter to a smaller diameter.
- 410. The lysing tip of example 409, wherein coupling tips are formed on opposing ends of the at least one lysing rod, and wherein the taper of each of the inner tunnels of the outer bead sleeves is configured to engage one of the coupling tips.
- 411. The lysing tip of example 394, wherein the at least one lysing rod extends along a treatment side of the lysing tip, and wherein the lysing tip further comprises a support member extending along a side of the lysing tip opposite from the treatment side.
- 412. The lysing tip of example 411, wherein the support member defines a bow shape, and wherein the support member is coupled at opposite ends of the support member to the at least one lysing rod.
- 413. The lysing tip of example 412, wherein the at least one lysing rod extends through openings in the support member formed at the opposite ends of the support member.
- 414. The lysing tip of example 394, wherein at least one of the plurality of beads comprises at least one facet comprising a flattened region formed on the at least one of the plurality of beads.
- 415. The lysing tip of example 394, further comprising a support member extending along a side of the lysing tip opposite from the treatment side, wherein the support member extends proximally behind each of a plurality of middle beads positioned between two opposing outer beads positioned at opposite ends of the at least one lysing rod.
- 416. The lysing tip of example 415, wherein the lysing tip is configured to perform in a relaxed configuration in which each of the middle beads does not contact the support member and a flexed configuration in which at least one of the middle beads contacts the support member.
- 417. The lysing tip of example 415, wherein at least a subset of the plurality of beads is configured to rotate about the at least one lysing rod, wherein the lysing tip is configured such that each of the middle beads does not contact the support member in a relaxed configuration, and wherein the lysing tip is configured such that at least one of the middle beads contacts the support member following sufficient rotation of the at least one of the middle beads about the at least one lysing rod so as to prevent further rotation.
- 418. The lysing tip of example 394, wherein each of the plurality of beads comprises at least one of a plastic, a gelatin, and a hydrogel material.
- 419. The lysing tip of example 418, wherein each of the plurality of beads is overmolded onto one of the plurality of sleeves.
- 420. The lysing tip of example 394, wherein each of at least a subset of the plurality of beads comprises an at least substantially annular bead structure.
- 421. The lysing tip of example 420, wherein each of the at least a subset comprises an annular bead structure having at least one of a circular shape and an oval shape in cross-section.
- 422. The lysing tip of example 420, wherein the plurality of beads comprises a first outer bead, a second outer bead positioned opposite from the first outer bead, and at least one middle bead positioned in between the first outer bead and the second outer bead, wherein the at least one middle bead defines a partial annular shape.
- 423. The lysing tip of example 422, wherein the at least one middle bead comprises opposite ends each terminating in a knob at a proximal side of the at least one middle bead.
- 424. The lysing tip of example 420, wherein each of the at least a subset comprises a bead hub positioned within the annular bead structure, and wherein each of the bead hubs is configured to couple the annular bead structure with one of the plurality of sleeves.
- 425. The lysing tip of example 424, wherein each of the at least a subset further comprises at least one spoke extending from the bead hub to the annular bead structure.
- 426. The lysing tip of example 424, wherein each of the at least a subset further comprises a bead hub frame extending continuously from the bead hub to the annular bead structure without protruding laterally beyond an upper profile of the annular bead structure.
- 427. The lysing tip of example 420, wherein the at least one lysing rod comprises a plurality of deformed regions corresponding with the plurality of sleeves so as to prevent each of the plurality of sleeves from being removed from a predefined region on the at least one lysing rod.
- 428. The lysing tip of example 420, wherein the plurality of beads comprises a first outer bead, a second outer bead positioned opposite from the first outer bead, and at least one middle bead positioned in between the first outer bead and the second outer bead, wherein each of the first outer bead and the second outer bead defines a full annular structure extending in a full perimeter about a respective sleeve of the plurality of sleeves, and wherein the at least one middle bead defines a partial annular structure extending in a partial perimeter about a respective sleeve the plurality of sleeves.
- 429. The lysing tip of example 428, wherein each of the at least one middle bead comprises knobs formed at opposing ends of the partial annular structure.
- 430. The lysing tip of example 428, wherein the at least one lysing rod extends along a treatment side of the lysing tip, wherein the lysing tip further comprises a support member extending along a side of the lysing tip opposite from the treatment side, and wherein the at least one middle bead is configured to operate in a relaxed configuration in which the at least one middle bead is spaced apart from the support member, a first flexed configuration in which the at least one middle bead rotates about the lysing rod in a first direction and a first terminal end of the at least one middle bead contacts the support member to inhibit further rotation in the first direction, and a second flexed configuration in which the at least one middle bead rotates about the lysing rod in a second direction and a second terminal end of the at least one middle bead opposite from the first terminal end contacts the support member to inhibit further rotation in the second direction.
- 431. The lysing tip of example 420, wherein the plurality of beads comprises a first outer bead, a second outer bead positioned opposite from the first outer bead, and at least one middle bead positioned in between the first outer bead and the second outer bead, wherein each of the plurality of beads defines a full annular structure extending in a full perimeter about a respective sleeve of the plurality of sleeves.
- 432. The lysing tip of example 431, wherein each of the at least one middle bead comprises a full annular structure comprising a rounded leading end and a flattened trailing end.
- 433. The lysing tip of example 432, wherein the first outer bead and the second outer bead comprise a rounded leading end and a rounded trailing end.
- 434. The lysing tip of example 431, wherein each of the at least a subset comprises a bead hub positioned within the annular bead structure, wherein each of the bead hubs is configured to couple the annular bead structure with one of the plurality of sleeves, and wherein the first outer bead and the second outer bead are coupled directly to an interior surface of the full annular structure.
- 435. The lysing tip of example 420, wherein each of the plurality of beads comprises an annular structure, and wherein the annular structure comprises an annular band structure.
- 436. The lysing tip of example 435, wherein the annular band structure is defined by an upper surface extending in a full perimeter about the annular band structure, wherein the annular band structure is further defined by a lower surface extending in a full perimeter about the annular band structure, and wherein the upper surface is at least substantially parallel to the lower surface about the full perimeter.
- 437. The lysing tip of example 435, wherein the annular band structure comprises a resiliently flexible material such that the annular band structure can deform during a surgical procedure and automatically return to a relaxed configuration.
- 438. The lysing tip of example 437, wherein each of the plurality of beads comprises a bead hub positioned within the annular band structure, wherein each of the bead hubs is configured to couple the annular band structure with one of the plurality of sleeves.
- 439. The lysing tip of example 438, wherein each of the plurality of beads further comprises at least two spokes extending between the bead hub and the annular band structure.
- 440. The lysing tip of example 439, wherein the at least two spokes comprises only a first spoke extending between an upper portion of the annular band structure and a second spoke extending between a lower portion of the annular band structure, and wherein the first spoke and the second spoke are positioned and configured to allow the annular band structure to compress during a surgical procedure.
- 441. The lysing tip of example 440, wherein the first spoke and the second spoke are positioned and configured to allow the annular band structure to compress between an upper portion and a lower portion of the annular band structure and to compress between a distal portion and a proximal portion of the annular band structure.
- 442. The lysing tip of example 437, wherein the annular band structure is configured to compress during a surgical procedure to reduce a cross-sectional profile of the annular band structure between an upper end of the annular band structure and a lower end of the annular band structure.
- 443. The lysing tip of example 442, wherein the annular band structure is further configured such that, upon encountering sufficiently dense tissue at a distal tip of the annular band structure, the at least one lysing rod advances in a distal direction relative to the annular band structure.
- 444. The lysing tip of example 442, wherein the annular band structure is configured to elongate between a distal end and a proximal end of the annular band structure as the annular band structure compresses to reduce the cross-sectional profile.
- 445. A system comprising the lysing tip of example 394, wherein the system further comprises:
- a cannula configured to deliver the lysing tip therethrough; and
- a deployment assembly configured to reposition the lysing tip from a delivery configuration and a treatment configuration.
- 446. The system of example 445, wherein the deployment assembly comprises a pair of actuation rods coupled to the lysing tip, wherein the pair of actuation rods is configured to pivot the lysing tip between the delivery and treatment configurations.
- 447. The system of example 446, wherein, in the delivery configuration, an axis of the at least one lysing rod extends along an axis of the cannula, and wherein, in the treatment configuration, the axis of the at least one lysing rod extends at least substantially perpendicular to the axis of the cannula outside of a distal opening of the cannula.
- 448. A system for delivery of tissue modification energy during a surgical procedure, the system comprising:
- a tissue modification tip comprising an energy window configured to deliver energy therethrough for modification of patient tissue during a surgical procedure;
- at least one cannula configured to deliver the tissue modification tip therethrough; and
- a deployment assembly comprising at least one actuation rod, wherein the at least one actuation rod is configured to pivot the tissue modification tip between a delivery configuration in which an axis of the energy window extends along an axis of the cannula and a treatment configuration in which the axis of the energy window extends at least substantially perpendicular to the axis of the cannula outside a distal opening of the at least one cannula.
- 449. The system of example 448, wherein the at least one cannula comprises an inner cannula and an outer cannula.
- 450. The system of example 449, wherein the tissue modification tip is configured to be fully received within the outer cannula in the delivery configuration, and wherein the tissue modification tip is configured to be unable to be fully received within the inner cannula in the delivery configuration.
- 451. The system of example 448, wherein the energy window comprises an energy window array comprising a plurality of isolated energy window termini.
- 452. The system of example 451, wherein the energy window is configured to deliver electrosurgical energy through each of the plurality of isolated energy window termini.
- 453. The system of example 452, wherein the energy window is configured to deliver coagulation electrosurgical energy through each of the plurality of isolated energy window termini.
- 454. The system of example 451, wherein the energy window is configured to deliver pulsed electrosurgical energy through each of the plurality of isolated energy window termini.
- 455. The system of example 454, wherein the pulsed electrosurgical energy is configured such that, upon moving the tissue modification tip through a patient's tissue, intermittent islands of unmodified tissue are created in between tissue modified by the energy window.
- 456. The system of example 451, wherein at least a first subset of the plurality of isolated energy window termini is both physically and electrically isolated from at least a second subset of the plurality of isolated energy window termini.
- 457. The system of example 456, wherein each of the first subset of the plurality of isolated energy window termini is configured to deliver a first modality of energy, and wherein the second subset of the plurality of isolated energy window termini is configured to deliver a second modality of energy that differs from the first modality.
- 458. The system of example 457, wherein the first modality comprises an electrosurgical energy of a first frequency, and wherein the second modality comprises an electrosurgical energy of a second frequency distinct from the first frequency.
- 459. The system of example 448, wherein the at least one actuation rod comprises:
- a central actuation rod coupled to a central portion of the tissue modification tip; and
- a side actuation rod coupled at a first end of the side actuation rod to the tissue modification tip adjacent a first end of the tissue modification tip and coupled to the central actuation rod at a second end of the side actuation rod opposite from the first end of the side actuation rod.
- 460. The system of example 448, further comprising at least one canal configured to extend through the at least one cannula to deliver fluid to a surgical site adjacent to the tissue modification tip during a surgical procedure.
- 461. A system for delivery of tissue modification energy during a surgical procedure, the system comprising:
- a tissue modification tip comprising an energy window configured to deliver energy therethrough for modification of patient tissue during a surgical procedure;
- a grasping pad; and
- a first instrument configured to selectively couple with the tissue modification tip, wherein the first instrument is configured to selectively couple with the tissue modification tip at the grasping pad.
- 462. The system of example 461, wherein the energy window comprises an elongated energy window extending along an upper surface of the tissue modification tip.
- 463. The system of example 462, wherein the tissue modification tip comprises a plurality of bars extending across the elongated energy window, and wherein the plurality of bars is configured to separate the elongated energy window into a plurality of isolated energy windows.
- 464. The system of example 463, wherein the elongated energy window comprises a primary axis extending from a first side of the elongated energy window to a second side of the elongated energy window opposite from the first side, and wherein each of the plurality of bars extends across the elongated energy window in a direction at least substantially perpendicular to the primary axis.
- 465. The system of example 461, wherein the energy window comprises a plurality of isolated energy window termini formed on an upper surface of the tissue modification tip.
- 466. The system of example 461, wherein the grasping pad is electrically coupled with the energy window, and wherein the first instrument is configured to deliver energy to the energy window through the grasping pad while the tissue modification tip is coupled with the first instrument.
- 467. The system of example 461, further comprising an energy conduit coupled with the energy window.
- 468. The system of example 467, wherein the energy conduit comprises a wire extending from the energy window and configured to extend through a lumen formed in the first instrument.
- 469. The system of example 461, wherein the energy window is configured to deliver at least one of LASER, intense pulse light, resistant heating, radiant heat, thermochromic, ultrasound, and microwave energy.
- 470. The system of example 461, wherein the tissue modification tip further comprises at least one of an energy window tongue and an energy window slot configured to couple with a corresponding slot or tongue of the first instrument, and wherein the at least one of an energy window tongue and an energy window slot is configured to deliver energy therethrough to the energy window from the first instrument.
- 471. The system of example 470, wherein the tissue modification tip comprises an energy window tongue formed on the grasping pad, wherein the first instrument comprises a pair of jaws configured to grasp the grasping pad, wherein the first instrument comprises an energy window slot configured to receive the energy window tongue, and wherein the energy window slot is formed on at least one of the pair of jaws.
- 472. An electrosurgical system, comprising:
- a lysing tip configured for delivery of electrosurgical energy, wherein the lysing tip comprises:
- a first lysing tip portion comprising an energy delivery side configured to receive and deliver electrosurgical energy for one or more of tissue dissection and modification and an orientational-deployment side opposite from the energy delivery side;
- a second lysing tip portion pivotably coupled with the first lysing tip portion and comprising an energy delivery side configured to receive and deliver electrosurgical energy for one or more of tissue dissection and modification and an orientational-deployment side opposite from the energy delivery side, wherein the lysing tip is configured to be repositioned between a delivery configuration in which the energy delivery side of the first lysing tip portion is positioned adjacent to the energy delivery side of the second lysing tip portion and a treatment configuration in which the energy delivery side of the first lysing tip portion and the energy delivery side of the second lysing tip portion collectively define an energy delivery side of the lysing tip; and
- a deployment assembly coupled with the lysing tip, wherein the deployment assembly is configured to allow for selective repositioning between the delivery configuration and the treatment configuration.
- 473. The system of example 472, wherein each of the first tip portion and the second tip portion comprises a plurality of protrusions and at least one recession positioned between at least two adjacent protrusions in the plurality of protrusions.
- 474. The system of example 473, wherein the lysing tip comprises at least one lysing member forming a lysing segment between each two adjacent protrusions.
- 475. The system of example 473, wherein the lysing tip is configured such that at least a subset of the plurality of protrusions of the first tip portion nests within at least a subset of the at least one recession of the second tip portion in the delivery configuration.
- 476. The system of example 472, wherein the first tip portion is configured to extend at least substantially parallel to the second tip portion in the delivery configuration.
- 477. The system of example 472, wherein the first tip portion is configured to extend adjacent to the second tip portion in the treatment configuration such that the orientational-deployment side of the first tip portion extends at least substantially co-planar relative to the orientational-deployment side of the second tip portion.
- 478. The system of example 472, wherein the lysing tip is configured such that the first tip portion may be approximated with the second tip portion during a surgical procedure to clamp patient tissue therebetween.
- 479. The system of example 472, wherein the lysing tip is configured to operate in an intermediate configuration between the treatment configuration and the delivery configuration, wherein, in the intermediate configuration, the orientational-deployment sides of the first and second tip portions extend at an acute angle relative to one another, and wherein the lysing tip is configured to deliver electrosurgical energy to both the first and second tip portions in the intermediate configuration.
- 480. The system of example 472, wherein the first tip portion comprises at least one lysing segment configured to deliver electrosurgical energy therethrough, wherein the second tip portion comprises at least one lysing segment configured to deliver electrosurgical energy therethrough, and wherein the at least one lysing segment of the first tip portion is electrically isolated from the at least one lysing segment of the second tip portion.
- 481. The system of example 480, wherein the lysing tip comprises a bipolar lysing tip.
- 482. The system of example 472, wherein the lysing tip comprises a bipolar lysing tip, wherein the first tip portion comprises at least one lysing segment configured to deliver electrosurgical energy therethrough, wherein the second tip portion comprises at least one lysing segment configured to deliver electrosurgical energy therethrough, and wherein the lysing tip is configured such that, in the treatment configuration, each lysing segment of the first and second tip portions is configured to deliver electrosurgical energy of an opposite polarity relative to each adjacent lysing segment of the first and second tip portions.
- 483. A method for electrosurgically treating patient tissue, the method comprising the steps of:
- delivering a lysing tip through a first cannula in a delivery configuration, wherein the lysing tip comprises:
- a first lysing tip portion comprising an energy delivery side configured to receive and deliver electrosurgical energy for one or both of tissue dissection and modification and an orientational-deployment side opposite from the energy delivery side;
- a second lysing tip portion pivotably coupled with the first lysing tip portion and comprising an energy delivery side configured to receive and deliver electrosurgical energy for tissue dissection and/or modification and an orientational-deployment side opposite from the energy delivery side, wherein at least one of the energy delivery side and the orientational-deployment side of both the first lysing tip portion and the second lysing tip portion faces an inner wall of the cannula in the delivery configuration;
- reconfiguring the lysing tip to a treatment configuration by pivoting the first lysing tip portion relative to the second lysing tip portion; and
- delivering electrosurgical energy to the first and second lysing tip portions to treat patient tissue.
- 484. The method of example 483, wherein the lysing tip is configured in the delivery configuration such that the energy delivery side of the first lysing tip portion faces the energy delivery side of the second lysing tip portion.
- 485. The method of example 484, wherein the step of reconfiguring the lysing tip to a treatment configuration comprises pivoting the first lysing tip portion relative to the second lysing tip portion such that the first lysing tip portion extends at an acute angle relative to the second lysing tip portion.
- 486. The method of example 485, further comprising:
- positioning at least one of a duct and a blood vessel of a patient in between the first lysing tip portion and the second lysing tip portion; and
- approximating the first and second lysing tip portions to clamp the at least one of a duct and a blood vessel therebetween.
- 487. The method of example 484, wherein the step of reconfiguring the lysing tip to a treatment configuration comprises pivoting the first lysing tip portion relative to the second lysing tip portion such that the first lysing tip portion is aligned with the second lysing tip portion and such that the energy delivery sides of the first and second lysing tip portions extend in at least substantially the same direction.
- 488. The method of example 484, wherein the step of reconfiguring the lysing tip to a treatment configuration comprises pivoting the first lysing tip portion relative to the second lysing tip portion such that the first lysing tip portion and the second lysing tip portion are at least substantially perpendicular to an axis of the first cannula.
- 489. The method of example 488, wherein, in the treatment configuration, at least one of the first and second lysing tip portions extend beyond a cross-sectional profile of the first cannula.
- 490. The method of example 489, wherein, in the treatment configuration, both the first and second lysing tip portions extend beyond the cross-sectional profile of the first cannula.
- 491. A method for performing an electrosurgical procedure, the method comprising the steps of:
- delivering a lysing tip through an entrance incision into a patient's body in a delivery configuration, wherein the lysing tip comprises:
- a plurality of protrusions; and
- at least one lysing segment positioned between at least two adjacent protrusions in the plurality of protrusions;
- reconfiguring the lysing tip to a treatment configuration; and
- passing the lysing tip to a target tissue area within the patient's body.
- 492. The method of example 491, wherein the step of delivering a lysing tip through an entrance incision into a patient's body in a delivery configuration comprises delivering the lysing tip through a first cannula into the patient's body in the delivery configuration.
- 493. The method of example 492, wherein the lysing tip extends at least substantially along an axis of the first cannula in the delivery configuration, and wherein the step of reconfiguring the lysing tip to a treatment configuration comprises pivoting the lysing tip outside of a distal end of the first cannula such that at least one end of two opposing ends of the lysing tip extends beyond a cross-sectional profile of the first cannula.
- 494. The method of example 491, further comprising setting a threshold temperature for operation of the lysing tip.
- 495. The method of example 494, wherein the threshold temperature comprises at least one of a threshold temperature of patient tissue and a threshold temperature of at least a portion of the lysing tip.
- 496. The method of example 491, further comprising setting an energy level for delivery of electrosurgical energy to the lysing tip.
- 497. The method of example 491, wherein the step of delivering the lysing tip comprises inserting the lysing tip through the entrance incision through a first cannula and releasing the lysing tip, and wherein the step of reconfiguring the lysing tip to a treatment configuration comprises delivering a grasping/control instrument into the patient's body adjacent to the lysing tip and coupling the lysing tip with the grasping/control instrument.
- 498. The method of example 491, further comprising delivering electrosurgical energy to the at least one lysing segment.
- 499. The method of example 491, further comprising:
- obtaining sensor data;
- comparing the sensor data with a threshold; and
- upon detecting that a parameter of the sensor data has exceeded the threshold, reducing energy delivered to the lysing tip.
- 500. The method of example 499, wherein the sensor data comprises temperature data, and wherein the threshold comprises a temperature threshold.
- 501. The method of example 491, further comprising receiving location data associated with the lysing tip during a surgical procedure.
- 502. The method of example 501, wherein the step of receiving location data comprises receiving RFID tag data from an RFID tag located on the lysing tip.
- 503. The method of example 501, further comprising receiving temperature data from a temperature sensor on the lysing tip.
- 504. The method of example 503, further comprising combining the temperature data and the location data.
- 505. The method of example 504, further comprising creating an image using both the temperature data and the location data.
- 506. The method of example 505, wherein the image allows a user to determine which regions within a patient's body have been adequately treated using the lysing tip.
- 507. The method of example 505, wherein the image allows a user to determine which regions within a patient's body have exceeded a threshold temperature resulting from use of the lysing tip.
- 508. The method of example 491, wherein the entrance incision comprises a first length, wherein the lysing tip comprises a greatest dimension, and wherein the first length is less than the greatest dimension of the lysing tip.
- 509. The method of example 508, wherein the greatest dimension of the lysing tip is defined between a first outer protrusion of the plurality of protrusions and a second outer protrusion of the plurality of protrusions opposite from the first outer protrusion.
- 510. The method of example 509, wherein the step of delivering the lysing tip comprises inserting the lysing tip through the entrance incision through a first cannula in the delivery configuration and extending the lysing tip through a distal opening of the first cannula, and wherein the step of reconfiguring the lysing tip to the treatment configuration comprises rotating the lysing tip within the patient's body such that the greatest dimension is greater than a cross-sectional diameter of the first cannula and such that the lysing tip cannot be received back into the first cannula in the treatment configuration.
- 511. The method of example 510, wherein the step of delivering the lysing tip comprises inserting the lysing tip through the entrance incision through a first cannula extending over a second cannula.
- 512. The method of example 511, wherein the lysing tip is configured such that it may not be received within the second cannula in the delivery configuration.
- 513. The method of example 491, further comprising creating a path to a target organ using the lysing tip.
- 514. The method of example 513, wherein the step of creating a path to the target organ comprises activating an electrosurgical generator and delivering electrosurgical energy from the electrosurgical generator to the at least one lysing segment.
- 515. The method of example 513, further comprising identifying critical tissue that is not to be treated using the lysing tip, and wherein the step of creating the path to the target organ comprises creating a path to the target organ that avoids the critical tissue.
- 516. The method of example 513, further comprising expanding the path to the target organ using the lysing tip.
- 517. The method of example 516, wherein the plurality of protrusions comprises a first outer protrusion and a second outer protrusion opposite from the first outer protrusion, wherein the first outer protrusion extends in a first direction, wherein the second outer protrusion extends in a second direction, and wherein the first direction extends at an angle relative to the second direction.
- 518. The method of example 517, wherein the step of expanding the path to the target organ comprises using a side-to-side fanning motion to expand the path.
- 519. The method of example 491, further comprising:
- creating a path to a target organ using the lysing tip;
- reconfiguring the lysing tip from the treatment configuration to the delivery configuration;
- withdrawing the lysing tip from the patient's body through the entrance incision;
- inserting a tissue modification tip comprising an energy window configured to deliver energy therethrough into the patient's body; and
- extending the tissue modification tip through the path to the target tissue area.
- 520. The method of example 519, further comprising at least one of removing an organ and accessing an organ at the target tissue area using the lysing tip.
- 521. The method of example 520, further comprising using the tissue modification tip to achieve hemostasis at the target tissue area.
- The method of example 520, wherein the organ comprises at least one of a muscle, a parotid gland, a salivary gland, a thyroid gland, a lung, a heart, a liver, a pancreas, a spleen, a gallbladder, a kidney, an adrenal gland, a prostate, an ovary, a uterus, a bladder, a blood vessel, a nerve, a lymph node, and a bone.
- 522. The method of example 491, further comprising:
- reconfiguring the lysing tip from the treatment configuration to the delivery configuration; and
- withdrawing the lysing tip from the patient's body.
- 523. The method of example 522, wherein the step of reconfiguring the lysing tip from the treatment configuration to the delivery configuration comprises rotating the lysing tip such that a primary axis of the lysing tip extends at least substantially along a direction of withdrawal of the lysing tip.
- 524. The method of example 523 wherein the step of reconfiguring the lysing tip from the treatment configuration to the delivery configuration comprises rotating the lysing tip such that a primary axis of the lysing tip extends at least substantially along an axis of a cannula, and wherein the step of withdrawing the lysing tip comprises withdrawing the lysing tip through the cannula.
- 525. The method of example 491, further comprising creating a path to a site of herniated tissue using the lysing tip.
- 526. The method of example 525, further comprising dissecting tissue around the herniated tissue using the lysing tip to prepare the site for excision of the herniated tissue.
- 527. The method of example 526, further comprising using the lysing tip to excise at least a portion of the herniated tissue.
- 528. The method of example 527, further comprising applying energy to tissue remaining at the site following excision of the herniated tissue.
- 529. The method of example 528, wherein the step of applying energy to remaining tissue at the site following excision of the herniated tissue comprises applying energy using at least one of the lysing tip and a separate tissue modification tip.
- 530. The method of example 528, further comprising:
- binding at least some of the remaining tissue; and
- using at least one of the lysing tip and a separate tissue modification tip to induce supportive fibrosis at the site.
- 531. The method of example 491, CNS access further comprising creating a path to at least one of the brain, spinal cord, and adjacent proximal nerves.
- 532. The method of example 491, further comprising creating a path to a peripheral nerve using the lysing tip.
- 533. The method of example 532, further comprising using the lysing tip to remove at least one of a tumor and fibrotic tissue from the peripheral nerve.
- 534. The method of example 533, wherein the step of using the lysing tip to remove at least one of a tumor and fibrotic tissue from the peripheral nerve is performed without delivering electrosurgical energy to the at least one lysing segment.
- 535. The method of example 534, wherein the step of creating a path to a peripheral nerve using the lysing tip is performed at least in part while delivering electrosurgical energy to the at least one lysing segment.
- 536. The method of example 533, further comprising, following the step of using the lysing tip to remove at least one of a tumor and fibrotic tissue from the peripheral nerve:
- activating the lysing tip so as to deliver electrosurgical energy through the at least one lysing segment; and
- inducing hemostasis at a site of removal of the at least one of a tumor and fibrotic tissue using the lysing tip.
- 537. The method of example 491, further comprising using the lysing tip to create at least a portion of a tissue flap.
- 538. The method of example 537, wherein the tissue flap comprises at least one of a skin flap, a muscle flap, and a mucosal flap.
- 539. The method of example 538, further comprising using the tissue flap in a breast reconstruction procedure wherein the tissue flap comprises at least one of a latissimus dorsi flap and a transverse rectus abdominus myocutaneous flap.
- 540. The method of example 491, using the lysing tip to create at least a portion of a tissue graft.
- 541. The method of example 541, wherein the tissue graft comprises at least one of a skin graft, fat graft, fascial graft, vascular graft, connective tissue graft, and mucosal graft.
- 542. The method of example 491, further comprising:
- creating a path to a target organ having a tumor using the lysing tip; and
- removing at least a portion of the tumor from the target organ.
- 543. The method of example 542, further comprising:
- activating an electrosurgical generator to deliver electrosurgical energy to the at least one lysing segment; and
- using the lysing tip to induce hemostasis following removal of the at least a portion of the tumor from the target organ.
- 544. The method of example 491, further comprising creating a tip deployment pocket within the patient's body.
- 545. The method of example 544, wherein the tip deployment pocket comprises a width running along or at least substantially parallel to a length of the entrance incision, and wherein the width of the tip deployment pocket is greater than the length of the entrance incision.
- 546. The method of example 545, wherein the lysing tip comprises a lysing tip length between a first outer protrusion of the plurality of protrusions and a second outer protrusion of the plurality of protrusions opposite from the first outer protrusion, and wherein the width of the tip deployment pocket is greater than or equal to the lysing tip length.
- 547. The method of example 546, wherein the width of the width of the tip deployment pocket is at least about 150% of the lysing tip length.
- 548. The method of example 544, wherein the tip deployment pocket comprises a rectangular shape.
- 549. The method of example 544, wherein the tip deployment pocket comprises a circular shape.
- 550. The method of example 544, wherein the step of creating a tip deployment pocket comprises:
- inserting a blunt instrument through the entrance incision; and
- using the blunt instrument to separate tissue adjacent to the entrance incision into upper and lower planes defining the tip deployment pocket.
- 551. The method of example 544, wherein the step of creating a tip deployment pocket is performed without using the lysing tip, and wherein the step of creating a tip deployment pocket is performed before the step of delivering a lysing tip through an entrance incision into a patient's body.
- 552. The method of example 551, wherein the step of delivering a lysing tip through an entrance incision into a patient's body comprises delivering the lysing tip through a cannula with an elongated axis of the lysing tip extending along an axis of the cannula.
- 553. The method of example 552, wherein the step of reconfiguring the lysing tip from the delivery configuration to the treatment configuration comprises:
- extending the lysing tip out of a distal end of the cannula into the tip deployment pocket; and
- rotating the lysing tip such that the elongated axis extends at an at least substantially perpendicular angle relative to the axis of the cannula in the tip deployment pocket.
- 554. The method of example 553, wherein the step of rotating the lysing tip comprises rotating the lysing tip such that at least one end of the lysing tip defining the elongated axis extends beyond a cross-sectional profile of the cannula.
- 555. The method of example 554, wherein the step of rotating the lysing tip comprises rotating the lysing tip such that both opposing ends of the lysing tip defining the elongated axis extend beyond a cross-sectional profile of the cannula.
- 556. The method of example 553, further comprising using the lysing tip to create a path to at least one of an apocrine gland and an eccrine gland.
- 557. The method of example 556, further comprising:
- activating an electrosurgical generator to deliver electrosurgical energy to the at least one lysing segment; and
- using the lysing tip to apply electrosurgical energy to the at least one of an apocrine gland and an eccrine gland to incapacitate the at least one of an apocrine gland and an eccrine gland.
- 558. The method of example 544, further comprising using a fluid delivery canal to deliver fluid within the patient's body to a region adjacent to the lysing tip during a surgical procedure using the lysing tip.
- 559. The method of example 544, further comprising:
- using the lysing tip to create a path to a hair follicle region;
- activating an electrosurgical generator to deliver electrosurgical energy to the at least one lysing segment of the lysing tip; and
- using the lysing tip to apply electrosurgical energy to one or more hair follicles in the hair follicle region, wherein the electrosurgical energy results in the one or more hair follicles being incapacitated.
- 560. The method of example 544, wherein the entrance incision is between about 2 mm and about 12 mm in length, wherein the tip deployment pocket comprises a width running along or at least substantially parallel to the length of the entrance incision, and wherein the width of the tip deployment pocket is greater than the length of the entrance incision.
- 561. The method of example 560, wherein the width of the tip deployment pocket is greater than a length of the lysing tip extending between a first outer protrusion of the plurality of protrusions and a second outer protrusion of the plurality of protrusions opposite from the first outer protrusion.
- 562. The method of example 560, wherein the width of the tip deployment pocket is about 1 cm.
- 563. The method of example 562, wherein the tip deployment pocket comprises a rectangular shape, wherein a length of the tip deployment pocket extending at least substantially perpendicular to the width is between about 1 cm and about 2 cm.
- 564. The method of example 560, further comprising:
- using the lysing tip to create a first path from the tip deployment pocket to a first cellulite treatment zone; and
- using the lysing tip to treat cellulite in the first cellulite treatment zone.
- 565. The method of example 564, further comprising using the lysing tip to create a second path from the tip deployment pocket to the first cellulite treatment zone.
- 566. The method of example 565, wherein the second path is angled relative to the first path.
- 567. The method of example 564, further comprising:
- using the lysing tip to create a second path from the tip deployment pocket to a second cellulite treatment zone spaced apart from the first cellulite treatment zone; and
- using the lysing tip to treat cellulite in the second cellulite treatment zone.
- 568. The method of example 564, wherein the step of using the lysing tip to treat cellulite in the first cellulite treatment zone comprises:
- manipulating the first cellulite treatment zone to move a top portion of the first cellulite treatment zone into the first path; and
- advancing the lysing tip into the first cellulite treatment zone to treat cellulite in the top portion of the first cellulite treatment zone.
- 569. The method of example 568, wherein the step of using the lysing tip to treat cellulite in the first cellulite treatment zone further comprises:
- manipulating the first cellulite treatment zone to move a bottom portion of the first cellulite treatment zone into the first path; and
- advancing the lysing tip into the first cellulite treatment zone to treat cellulite in the bottom portion of the first cellulite treatment zone.
- 570. The method of example 564, wherein the step of using the lysing tip to treat cellulite in the first cellulite treatment zone comprises:
- delivering electrosurgical energy to the at least one lysing segment; and
- using the electrosurgical energy to denature tissues in the in the first cellulite treatment zone.
- 571. The method of example 564, wherein a single entrance incision is used to treat cellulite in a first plurality of cellulite treatment zones along the patient's first leg, and further comprising:
- forming a second entrance incision;
- forming a second tip deployment pocket; and
- using the lysing tip to treat cellulite in a second plurality of cellulite treatment zones along the patient's second leg from the second entrance incision.
- 572. The method of example 544, wherein the step of creating a tip deployment pocket comprises creating the tip deployment pocket adjacent to the entrance incision.
- 573. The method of example 544, further comprising:
- reconfiguring the lysing tip from the treatment configuration to the delivery configuration; and
- withdrawing the lysing tip through the entrance incision.
- 574. The method of example 573, wherein the step of reconfiguring the lysing tip from the treatment configuration to the delivery configuration comprises rotating the lysing tip such that an elongated axis of the lysing tip extends at least substantially in a withdrawal direction.
- 575. The method of example 574, wherein the withdrawal direction extends along an axis of a cannula, and wherein the step of withdrawing the lysing tip comprises withdrawing the lysing tip through the cannula.
- 576. The method of example 491, further comprising creating a tip deployment pocket within at least one of a patient's neck and head, wherein the surgical procedure comprises at least one of a facelift and a necklift procedure.
- 577. The method of example 576, further comprising forming at least one treatment path using the lysing tip from the tip deployment pocket along at least one of a patient's face and neck.
- 578. The method of example 577, wherein the step of forming at least one treatment path comprises forming a plurality of overlapping treatment paths using the lysing tip from the tip deployment pocket along the at least one of the patient's face and neck.
- 579. The method of example 578, further comprising activating the at least one lysing segment to deliver electrosurgical energy to tissue adjacent to the at least one treatment path using the lysing tip.
- 580. The method of example 577, further comprising:
- withdrawing the lysing tip from the entrance incision;
- inserting a tissue modification tip comprising an energy window configured to deliver energy therethrough through the entrance incision; and
- using the tissue modification tip to modify tissue adjacent to the at least one treatment path to tighten the tissue adjacent to the at least one treatment path.
- 581. The method of example 580, wherein the energy window is positioned on an upper surface of the tissue modification tip.
- 582. The method of example 581, wherein the step of using the tissue modification tip to modify tissue adjacent to the at least one treatment path comprises positioning the energy window to face an upper surface of the at least one treatment path closer to an exterior surface of the patient's skin.
- 583. The method of example 581, wherein the step of using the tissue modification tip to modify tissue adjacent to the at least one treatment path comprises positioning the energy window to face a lower surface of the at least one treatment path further from an exterior surface of the patient's skin.
- 584. The method of example 491, further comprising using the lysing tip to dissect the patient's scalp.
- 585. The method of example 491, further comprising:
- forming a plurality of entrance incisions;
- inserting the lysing tip within each of the entrance incisions; and
- using the lysing tip to dissect the patient's scalp adjacent to each of the entrance incisions.
- 586. The method of example 491, further comprising creating a tip deployment pocket adjacent to the patient's scalp.
- 587. The method of example 586, further comprising:
- inserting the lysing tip in the tip deployment pocket; and
- after inserting the lysing tip in the tip deployment pocket, reconfiguring the lysing tip from the delivery configuration to the treatment configuration in the tip deployment pocket.
- 588. The method of example 587, further comprising:
- forming a plurality of entrance incisions adjacent to the patient's scalp;
- forming a plurality of tip deployment pockets adjacent to the plurality of entrance incisions;
- deploying the lysing tip in each of the plurality of tip deployment pockets; and
- forming a scalp dissection path using the lysing tip from each of the tip deployment pockets to separate the patient's scalp from its underlying structure.
- 589. The method of example 491, wherein the electrosurgical procedure comprises installing at least one of a biomedical implant and a cosmetic implant within the patient, and further comprising creating a path to a location adjacent to an implant zone where the at least one of a biomedical implant and a cosmetic implant will be installed using the lysing tip.
- 590. The method of example 589, further comprising using the lysing tip to create an implant pocket in tissue in the implant zone, wherein the implant pocket is configured to receive the at least one of a biomedical implant and a cosmetic implant.
- 591. The method of example 590, wherein the at least one of a biomedical implant and a cosmetic implant comprises a biomedical implant, and wherein the biomedical implant comprises at least one of a pump, a pacemaker, a neurological implant, a drug delivery device, a tracking implant, and an ID chip.
- 592. The method of example 590, wherein the at least one of a biomedical implant and a cosmetic implant comprises a cosmetic implant, and wherein the cosmetic implant comprises at least one of a skin implant, a breast implant, a face implant, and a muscle implant.
- 593. The method of example 590, further comprising:
- forming a tip deployment pocket; and
- deploying the lysing tip in the tip deployment pocket by inserting the lysing tip in the tip deployment pocket and reconfiguring the lysing tip from the delivery configuration to the treatment configuration in the tip deployment pocket.
- 594. The method of example 593, wherein the tip deployment pocket is formed adjacent to the implant zone.
- 595. The method of example 593, wherein the tip deployment pocket is formed adjacent to the entrance incision.
- 596. The method of example 593, further comprising advancing the at least one of a biomedical implant and a cosmetic implant to the implant zone and inserting the at least one of a biomedical implant and a cosmetic implant in the implant pocket.
- 597. The method of example 491, wherein the electrosurgical procedure comprises at least one of a capsulotomy and a capsulectomy.
- 598. The method of example 597, further comprising using the lysing tip to create a path to an implant having a capsule of scar tissue adjacent to the implant.
- 599. The method of example 598, further comprising using the lysing tip to separate at least a portion of the capsular fibrous tissue from the implant.
- 600. The method of example 598, wherein the implant comprises a breast implant.
- 601. The method of example 598, wherein the implant comprises a hip implant.
- 602. An electrosurgical lysing tip, comprising:
- a first outer protrusion;
- a second outer protrusion opposite from the first outer protrusion;
- at least one inner bead positioned in between the first outer protrusion and the second outer protrusion, wherein each of the at least one inner bead defines an inner protrusion;
- at least one lysing member defining at least one lysing segment between each pair of adjacent protrusions; and
- a support member extending between the first outer protrusion and the second outer protrusion, wherein the support member is configured to facilitate coupling of the lysing tip to a surgical tool used to control the lysing tip during a surgical procedure within a patient's body.
- 603. The electrosurgical lysing tip of example 602, wherein the first outer protrusion is defined by a first outer bead, and wherein the second outer protrusion is defined by a second outer bead positioned on an opposite end of the lysing tip relative to the first outer bead.
- 604. The electrosurgical lysing tip of example 603, wherein each of the first outer bead and the second outer bead comprises a leading end protruding distally of the at least one lysing member, and wherein each of the first outer bead and the second outer bead comprises a trailing end protruding proximally from the support member.
- 605. The electrosurgical lysing tip of example 603, wherein the first outer bead is non-rigidly coupled to the support member at a first end of the support member, and wherein the second outer bead is non-rigidly coupled to the support member at a second end of the support member opposite from the first end.
- 606. The electrosurgical lysing tip of example 603, wherein the first outer bead and the second outer bead each comprises an inner recess, and wherein each inner recess is configured to receive a respective portion of the support member therein.
- 607. The electrosurgical lysing tip of example 606, wherein each inner recess is configured to receive a respective end portion of the support member such that each opposing end of the support member terminates in an inner recess.
- 608. The electrosurgical lysing tip of example 606, wherein each inner recess is configured to loosely receive a respective portion of the support member therein such that the first outer bead and the second outer bead can move relative to the support member during a surgical procedure.
- 609. The electrosurgical lysing tip of example 602, wherein the first outer protrusion comprises an integral portion of the support member at a first end of the support member, and wherein the second outer protrusion comprises an integral portion of the support member at a second end of the support member opposite from the first end.
- 610. The electrosurgical lysing tip of example 602, wherein the first outer protrusion and the second outer protrusion each comprises a shape that at least substantially mimics the shapes of each of the at least one inner bead along a leading end of the first outer protrusion and the second outer protrusion.
- 611. The electrosurgical lysing tip of example 602, wherein the first outer protrusion is defined by a first outer bead, wherein the second outer protrusion is defined by a second outer bead positioned on an opposite end of the lysing tip relative to the first outer bead, and wherein the first outer bead and the second outer bead each comprises an at least substantially ellipsoidal shape.
- 612. The electrosurgical lysing tip of example 611, wherein each of the at least one inner bead comprises a leading end having an at least substantially ellipsoidal shape.
- 613. The electrosurgical lysing tip of example 612, wherein each of the at least one inner bead further comprises a flattened trailing end.
- 614. The electrosurgical lysing tip of example 613, wherein each of the at least one inner bead comprises a flattened trailing end that terminates adjacent to the support member.
- 615. An electrosurgical system, comprising:
- a lysing tip comprising:
- a plurality of beads; and
- a lysing member extending through each of the plurality of beads such that each of the plurality of beads protrudes beyond the lysing member; and
- a surgical tool configured to selectively couple with the lysing tip, wherein the surgical tool comprises a pair of jaws configured to selectively engage at least a portion of the lysing tip.
- 616. The electrosurgical system of example 615, wherein the lysing member comprises a first coupling tip formed at a first end of the lysing member and a second coupling tip formed at a second end of the lysing member opposite from the first end, and wherein the surgical tool is configured to selectively engage the lysing tip at the first coupling tip and the second coupling tip.
- 617. The electrosurgical system of example 616, wherein the lysing member comprises a lysing rod comprising an at least substantially circular cross-section, and wherein the first and second coupling tips comprise enlarged portions of the lysing rod.
- 618. The electrosurgical system of example 616, wherein the first coupling tip comprises an enlarged end, wherein the second coupling tip comprises a second enlarged end, wherein a first jaw of the pair of jaws is configured to engage the first coupling tip at the first end, and wherein a second jaw of the pair of jaws is configured to engage the second coupling tip at the second end.
- 619. The electrosurgical system of example 615, wherein each of the plurality of beads is configured to rotate with respect to the lysing member.
- 620. The electrosurgical system of example 615, further comprising a plurality of spacers coupled with the lysing member, wherein each of the plurality of spacers is positioned between a pair of adjacent beads of the plurality of beads.
- 621. The electrosurgical system of example 620, further comprising a first outer spacer positioned in between a first outer bead of the plurality of beads and an adjacent bead and a second outer spacer positioned in between a second outer bead of the plurality of beads opposite from the first outer bead and an adjacent bead.
- 622. The electrosurgical system of example 615, wherein the surgical tool is configured to deliver electrosurgical energy to the lysing member when the lysing tip is selectively engaged with the surgical tool.
- 623. The electrosurgical system of example 622, wherein the surgical tool is configured to deliver electrosurgical energy to the lysing tip through at least one jaw of the pair of jaws.
- 624. The electrosurgical system of example 615, wherein each of the plurality of beads comprises an at least substantially ellipsoidal leading end.
- 625. The electrosurgical system of example 624, wherein each of the plurality of beads comprises a flattened trailing end.
- 626. An electrosurgical lysing tip, comprising:
- a plurality of beads;
- at least one lysing member extending at least partially through each of the plurality of beads to couple the plurality of beads together, wherein the at least one lysing member defines at least one lysing segment between each pair of adjacent beads of the plurality of beads;
- a treatment portion coupled with the at least one lysing member;
- a base portion removably couplable with the treatment portion and configured such that, following an electrosurgical procedure with the electrosurgical lysing tip, the treatment portion may be removed from the base portion and a new treatment portion with a new at least one lysing member and a new plurality of beads coupled with the base portion for a subsequent electrosurgical procedure.
- 627. The electrosurgical lysing tip of example 626, wherein the base portion comprises at least one hole configured to couple the base portion with a deployment assembly of a surgical instrument.
- 628. The electrosurgical lysing tip of example 626, wherein the base portion and the treatment portion together define a support member for the electrosurgical lysing tip, wherein the support member is configured to facilitate coupling of the electrosurgical lysing tip to a surgical instrument used to control the lysing tip during an electrosurgical procedure within a patient's body.
- 629. The electrosurgical lysing tip of example 628, wherein the treatment portion is configured to mate with the base portion such that the treatment portion defines a distal portion of the support member and the base portion defines a proximal portion of the support member.
The features, structures, steps, or characteristics disclosed herein in connection with one embodiment may be combined in any suitable manner in one or more alternative embodiments.
The term dissection may indicate the separation of tissues or of one tissue plane from another (ref: Free Online Medical Dictionary). Some also consider dissection to comprise separation of a single tissue into portions. Much of the bodies of animals and humans are formed from embryonic fusion planes. Many of the organs of the human or animal body may be categorized from the embryonic fusion planes from whence they came. The interfaces between organs may often be referred to as ‘tissue planes.’ Such planes may be considered substantially planar depending upon the size of a comparative planar living or inanimate object (such as a surgical instrument). Some embodiments disclosed herein may comprise cannula-delivered tissue dissectors (CDTD). Other embodiments disclosed herein may be used without a cannula and may therefore be considered non-cannula-delivered tissue dissectors (non-CDTD). Some embodiments may be used either with or without cannulas and therefore, depending upon the systems/procedure, may be considered CDTD or non-CDTD. Both the CDTD and non-CDTD embodiments disclosed herein may perform the functions of sharp dissection, blunt dissection, electrosurgical cutting and/or coagulation simultaneously without a surgeon having to switch instruments. Tissue modification may also be carried out.
Sharp dissection has been referred to by some as separation of tissues by means of the sharp edge of a knife or scalpel or with the inner sharp edge of scissors. Blunt dissection has been defined by Webster as surgical separation of tissue layers by means of an instrument without a cutting edge or by the fingers.
The term ‘minimally invasive surgery’ has been used to describe a procedure (surgical or otherwise) that is less invasive than open surgery used for the same purpose. Some minimally invasive procedures typically involve use of laparoscopic and/or endoscopic devices and manual and/or remote/computerized manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device, and are carried out through the skin or through a body cavity or anatomical opening. This may result in shorter hospital stays, or allow outpatient treatment (reference: Wikipedia).
Sometimes minimally invasive surgery is known as “keyhole” surgery and may be performed using one or more trocars and one or more laparoscopes and/or endoscopes and/or cannulae to access tissues within the body.
The term ‘open surgery’ is used to indicate cutting skin and tissues to ‘open the body’ so that the surgeon has direct access to the structures or organs involved. An incision may of the size that permits a surgeon's hands to enter the patient's body. The structures and tissues involved may be seen and touched and may be directly exposed to the air of the operating room.
The term “cannula,” as used herein, is intended to encompass any tube or tubular structure that is configured to be inserted into the body of a human or animal during a surgical procedure and facilitate selective movement of a surgical device and/or related components for performing delivery of the surgical device and/or surgical procedures with the surgical device. Tubular structures that contain fixed structures/elements therein, such as needle drivers or grasping instruments, are not considered cannulas as that term is used herein. Although often “trocars” are used in connection with cannulas, the term cannula, as used herein, is intended to encompass a trocar alone if such a trocar is capable of being used to insert a medical device into a body.
It may be advantageous to have a spot coagulator extend from an embodiment of the CDTD at such a distance and/or location that allows complete viewing and/or contact of a bleeding area with a portion of the spot coagulator (for example the distal end point of a tip of the coagulator). Such a probe may be deployable and may obtain electrical energy off of a conductive element located between the lysing elements of the tip and the plug.
BRIEF DESCRIPTION OF THE DRAWINGSThe written disclosure herein describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to certain of such illustrative embodiments that are depicted in the figures, in which:
FIG.1ais a perspective view of an embodiment of a system for delivery of a lysing tip through a cannula in a treatment configuration.
FIG.1bis a perspective view of the embodiment previously depicted inFIG.1ain a partially retracted configuration, in between the delivery and treatment configurations.
FIG.1cis a perspective view of the embodiment previously depicted inFIG.1ain the delivery configuration.
FIG.1dis an upper view of the lysing tip inFIG.1aand the distal portions of the cannulas.
FIG.1eis an upper view of lysing tip of the embodiment shown inFIG.1a.
FIG.1fis a rear perspective view of the lysing tip and actuation arms of the embodiment shown inFIG.1a.
FIG.1gis perspective view of the protrusion base of the embodiment shown inFIG.1a.
FIG.1his a perspective view of the lysing member of the embodiment shown inFIG.1a.
FIG.1iis a side view of a hand assembly that may be used with the embodiment shown inFIG.1a.
FIG.1jis perspective view of the embodiment shown inFIG.1aused in connection with a single cannula.
FIG.2ais a perspective view of an embodiment of a system for delivery of a lysing tip through a cannula in a treatment configuration.
FIG.2bis a perspective view of the embodiment previously depicted inFIG.2ain a partially retracted configuration, in between the delivery and treatment configurations.
FIG.2cis a perspective view of the embodiment previously depicted inFIG.2ain the delivery configuration.
FIG.2dis an upper view of the lysing tip inFIG.2aand the distal portion of the cannulas.
FIG.2eis a perspective view of the embodiment previously depicted inFIG.2aused in connection with a single cannula.
FIG.3ais a perspective view of an embodiment of a system for delivery of a lysing tip through a cannula in a treatment configuration.
FIG.3bis a perspective view of the embodiment previously depicted inFIG.3ain a partially retracted configuration, in between the delivery and treatment configurations.
FIG.3cis a perspective view of the embodiment previously depicted inFIG.3ain the delivery configuration.
FIG.3dis an upper view of the lysing tip inFIG.3aand the distal portion of the cannulas.
FIG.3eis a perspective view of the embodiment previously depicted inFIG.3aused in connection with a single cannula.
FIG.4ais a perspective view of an embodiment of a system for delivery of a bipolar lysing tip through a cannula in a treatment configuration.
FIG.4bis a perspective view of the embodiment previously depicted inFIG.4ain a partially retracted configuration, in between the delivery and treatment configurations.
FIG.4cis a perspective view of the embodiment previously depicted inFIG.4ain the delivery configuration.
FIG.4dis an upper view of the lysing tip inFIG.4aand the distal portion of the cannulas.
FIG.4eis a perspective view of the protrusion base of the embodiment previously depicted inFIG.4a.
FIG.4fis a perspective view of the lysing members of the embodiment previously depicted inFIG.4a.
FIG.4gis a rear perspective view of the embodiment previously depicted inFIG.4aincluding the rear of the lysing tip and the actuation rods.
FIG.4his a perspective view of the embodiment previously depicted inFIG.4aused in connection with a single cannula.
FIG.5ais a perspective view of an embodiment of a system for delivery of a lysing tip through a cannula in a treatment configuration.
FIG.5bis a perspective view of the embodiment previously depicted inFIG.5ain a partially retracted configuration, in between the delivery and treatment configurations.
FIG.5cis a perspective view of the embodiment previously depicted inFIG.5ain the delivery configuration.
FIG.5dis an upper view of the lysing tip inFIG.5aand the distal portion of the cannulas.
FIG.5eis a perspective view of the embodiment previously depicted inFIG.5aused in connection with a single cannula.
FIG.6ais a perspective view of an embodiment of a system for delivery of a lysing tip through a cannula in a treatment configuration.
FIG.6bis a perspective view of the embodiment previously depicted inFIG.6ain a partially retracted configuration, in between the delivery and treatment configurations.
FIG.6cis a perspective view of the embodiment previously depicted inFIG.6ain the delivery configuration.
FIG.6dis an upper view of the lysing tip inFIG.6aand the distal portion of the cannulas.
FIG.6eis a perspective view of the embodiment previously depicted inFIG.6aused in connection with a single cannula.
FIG.7ais a perspective view of an embodiment of a system for delivery of a lysing tip through a cannula via a grasping/control instrument.
FIG.7bis an upper plan view of the embodiment previously depicted inFIG.7a.
FIG.7cis a close-up side view of the embodiment previously depicted inFIG.7awherein a lysing tip is reattached.
FIG.7dis an upper plan view of the lysing tip of the embodiment previously depicted inFIG.7a.
FIG.7eis a side view of the embodiment previously depicted inFIG.7a, wherein the lysing tip is uncoupled from the grasping/control instrument.
FIG.7fis a side view of the grasping/control instrument of the embodiment previously depicted inFIG.7a.
FIG.8ais a perspective view of an embodiment of a system for delivery of a lysing tip through a single cannula via a grasping/control instrument further comprising a tether.
FIG.8bis a close-up side view of the distal end of the embodiment previously depicted inFIG.8awherein the tip is coupled to the instrument tip.
FIG.8cis a close-up side view of the distal end of the grasping/control instrument of the embodiment previously depicted inFIG.8a.
FIG.8dis a close-up, cross-sectional side view of the distal end of the embodiment previously depicted inFIG.8awherein the tip is coupled to the instrument tip.
FIG.8eis a close-up perspective view of the distal end of the embodiment previously depicted inFIG.8awherein the tip is uncoupled from the instrument tip yet tethered.
FIG.8fis a close-up perspective view of the distal end of the embodiment previously depicted inFIG.8awherein the tip is uncoupled from the instrument tip yet tethered and upside down.
FIG.9 is an upper plan view of a non-axial lysing tip.
FIG.10ais a perspective view of yet another embodiment of a system for delivery of a lysing tip through a cannula in a treatment configuration.
FIG.10bis an upper plan, close-up view of the embodiment previously depicted inFIG.10ain a treatment configuration.
FIG.10cis a close-up upper plan view of the embodiment previously depicted inFIG.10ashowing beads, protuberances, and lysing tip.
FIG.10dis a side view through the tunnel of a bead of the embodiment previously depicted inFIG.10a.
FIG.10eis a close-up, upper plan view of the lysing tip depicted inFIG.10cillustrating the lysing tip in a stressed/deformed state.
FIG.10fis an upper view of the embodiment previously depicted inFIG.10awith lysing tip in delivery configuration.
FIG.10gis a side view of the embodiment previously depicted inFIG.10aillustrating the coupling of the lysing member to the actuation rod.
FIG.10his an upper view of the embodiment previously depicted inFIG.10fillustrating that tip may not fit within one or more cannulas.
FIG.11ais a perspective view of an embodiment of a system for delivery of a lysing tip through a cannula in a treatment configuration.
FIG.11bis an upper plan, close-up view of the embodiment previously depicted inFIG.11ain a treatment configuration.
FIG.11cis a close-up upper plan view of the embodiment previously depicted inFIG.11ashowing beads, a spacer, and lysing tip.
FIG.11dis a side view through the tunnel of a bead with facets comprising the embodiment previously depicted inFIG.11a.
FIG.11eis a close-up upper plan view of the lysing tip depicted inFIG.11cillustrating the lysing tip in a stressed/deformed state with spacers.
FIG.11fis an upper view of the embodiment previously depicted inFIG.11billustrating that tip may not fit within one or more cannulas.
FIG.12acomprises a perspective view of a lysing member/lysing rod with a circular cross-section.
FIG.12bcomprises a perspective view of a lysing member/lysing rod with a triangular cross-section.
FIG.12ccomprises a perspective view of a lysing member/lysing rod with a rectangular cross-section.
FIG.12dcomprises a perspective view of a lysing member/lysing rod with a pentagonal cross-section.
FIG.12dxcomprises a perspective view of a lysing member/lysing rod having a pentagonal cross section that is twisted along its length.
FIG.12ecomprises a perspective view of a lysing member/lysing rod with a hexagonal cross-section.
FIG.12fcomprises a perspective view of a lysing member/lysing rod with a wedge cross-section.
FIG.12gcomprises a perspective view of a lysing member/lysing rod with a half-circle cross-section.
FIG.12hcomprises a perspective view of a spacer to a lysing tip with a hole through its length having a circular cross-section with non-beveled ends.
FIG.12icomprises a perspective view of a spacer to a lysing tip with a hole through its length having a circular cross-section with beveled ends.
FIG.12jcomprises a perspective view of a spacer to a lysing tip with a hole through its length having a circular cross-section with beveled ends and holes.
FIG.12kcomprises a perspective view of a spacer to a lysing tip with a hole through its length having a circular cross-section arced along its length.
FIG.12L comprises a perspective view of a spacer to a lysing tip with opposing loops connected by a rod in a relaxed state.
FIG.12mcomprises a perspective view of a spacer to a lysing tip with opposing loops connected by a rod in a stressed state.
FIG.12ncomprises a perspective view of a spacer to a lysing tip with a hole through its length having a triangular cross-section.
FIG.12ocomprises a perspective view of a spacer to a lysing tip with a hole through its length having a rectangular cross-section.
FIG.12pcomprises a perspective view of a spacer to a lysing tip with a hole through its length having a pentagonal cross-section.
FIG.12pxcomprises a perspective view of a spacer to a lysing tip with a hole through its length having a pentagonal cross section that is twisted along its length.
FIG.12qcomprises a perspective view of a spacer to a lysing tip with a hole through its length having a hexagonal cross-section.
FIG.12rcomprises a perspective view of a spacer to a lysing tip with a hole through its length having a blade-shaped cross-section with rounded edges.
FIG.12scomprises a perspective view of a spacer to a lysing tip with a hole through its length having a blade-shaped cross-section with flat edges.
FIG.12tcomprises a perspective view of a spacer to a lysing tip with a hole through its length having a spindle cross-section.
FIG.12aais a perspective view of a bead having a spherical shape.
FIG.12bbis a perspective view of a bead having a wheel shape.
FIG.12ccis a perspective view of a bead having a dodecahedron shape.
FIG.12ddis a perspective view of a bead having a substantially ellipsoidal shape.
FIG.12eeis a perspective view of a bead having a substantially ellipsoidal shape with facets.
FIG.12ffis a perspective view of a bead having a substantially ellipsoidal shape able to accept a sleeve.
FIG.12ggis a perspective view of a bead having a partially ellipsoidal shape with a flat proximal end and facets.
FIG.12hhis a perspective view of a bead having a partially ellipsoidal shape with two flat surfaces on its proximal end.
FIG.12iiis an upper view of a bead having a partially ellipsoidal shape with convex proximal end.
FIG.12jjis an upper view of a bead having a partially ellipsoidal shape with an asymmetric proximal end with facets.
FIG.12kkis an upper view of a bead having a partially ellipsoidal shape with an angular cut-out on its proximal end.
FIG.12LL is an upper view of a bead having a partially ellipsoidal shape with a concave proximal end.
FIG.12mmis a side view, from the outside, of an outer bead having a substantially annular shape.
FIG.12nnis a side view, from the inside, of bead depicted inFIG.12mm.
FIG.1200 is a side view of a deformable bead having a substantially annular shape.
FIG.12ppis a side view of a middle bead having a substantially annular shape and knobs on its proximal end.
FIG.12qqis a side view of a middle bead having a substantially annular shape and a cross-member at its proximal end.
FIG.12rris a side perspective view of a bead comprising a slot configured to engage a lysing member.
FIG.13ais a perspective view of an embodiment of a system for delivery of a lysing tip comprising a bar through a cannula in a treatment configuration.
FIG.13bis a perspective view of the embodiment previously depicted inFIG.13ain a partially retracted configuration, in between the delivery and treatment configurations.
FIG.13cis a perspective view of the embodiment previously depicted inFIG.13ain the delivery configuration.
FIG.13dis an upper view of the lysing tip inFIG.13aand the distal portion of the cannulas.
FIG.13eis a perspective view of the lysing tip of the embodiment previously depicted inFIG.13a.
FIG.13fis an upper view of the assembled lysing tip with actuation arms of the embodiment previously depicted inFIG.13a.
FIG.13gis an upper view of the embodiment previously depicted inFIG.13a, more specifically of the lysing tip without actuation arms.
FIG.13his an upper view of the lysing plate comprising the embodiment.
FIG.13iis a side view of the lysing tip.
FIG.14ais an upper perspective view of an alternative embodiment of a lysing tip delivered through one or more cannulas in the treatment configuration.
FIG.14bis an upper perspective view of the embodiment inFIG.14ain a partially deployed configuration, between the treatment and delivery configurations.
FIG.14cis an upper perspective view of the embodiment inFIG.14ain a delivery configuration.
FIG.14dis an upper view of the lysing tip inFIG.14aand the distal portion of the cannulas.
FIG.14eis a perspective view of the lysing tip of the embodiment previously depicted inFIG.14a.
FIG.14fis a side view of the lysing tip of the embodiment previously depicted inFIG.14a.
FIG.14gis an upper view of the embodiment previously depicted inFIG.14a, more specifically of the lysing tip without actuation arms.
FIG.14his an upper view of the lysing tip with certain components removed to view structures beneath.
FIG.14iis a perspective view of lysing tip in the delivery configuration being too large to enter the inner cannula but of sufficient dimensions to enter the outer cannula.
FIG.14jis an upper perspective view ofFIG.14i.
FIG.14kis a perspective view of the lysing tip ofFIG.14jin the delivery configuration with an inner cannula having a diameter smaller than tip width of the lysing tip.
FIG.14L is a perspective view of the embodiment ofFIG.14kwithout the outer cannula.
FIG.14mis a perspective view of the lysing tip ofFIG.14kin the delivery configuration with an inner cannula having a diameter smaller than tip width of the lysing tip which is covered by a protective sleeve.
FIG.14nis a perspective view of the embodiment ofFIG.14L without the outer cannula with the lysing tip covered by a protective sleeve.
FIG.14ois a perspective view of an alternative embodiment to that depicted inFIG.14ain which a treatment portion may be removed from the lysing tip.
FIG.14pis a perspective view of cross section taken along line A-A fromFIG.14r.
FIG.14qis a perspective view of the treatment portion of the embodiment depicted inFIG.14o.
FIG.14ris an exploded perspective view of the lysing tip of the embodiment ofFIG.14o.
FIG.14sis an exploded, side perspective cross-sectional view taken along line A-A fromFIG.14r
FIG.14tis an exploded, side cross-sectional view taken along line A-A fromFIG.14r.
FIG.15ais an upper perspective view of an alternative embodiment of a lysing tip delivered through one or more cannulas in the treatment configuration, said lysing tip being configured with one or more energy windows.
FIG.15bis an upper view of the embodiment previously depicted inFIG.15a, more specifically of the lysing tip with one or more energy windows and actuation arms.
FIG.15cis a front view of lysing tip of the embodiment previously depicted inFIG.15awith energy window strip.
FIG.15dis a close-up side view of lysing tip of the embodiment previously depicted inFIG.15awith energy window strip.
FIG.15eis a close-up perspective view of a bead of the embodiment previously depicted inFIG.15a.
FIG.15fis a front view showing lysing tip of the embodiment previously depicted inFIG.15awith energy window recessed within one or more cannulas.
FIG.15gis an exploded view of an energy window.
FIG.15his a front view of the insulation cover of the embodiment previously depicted inFIG.15a.
FIG.15iis a close-up sectioned side view of the outer bead showing the insertion of the insulation cover through the bead.
FIG.15jis a perspective view of a bipolar lysing tip of the embodiment ofFIG.15a.
FIG.15kis an upper plan view of a bipolar lysing tip of the embodiment ofFIG.15a.
FIG.16ais an upper perspective view of a bipolar embodiment of a CDTD system in the treatment configuration.
FIG.16bis a perspective view of the embodiment previously depicted inFIG.16ain a partially retracted configuration, in between the delivery and treatment configurations.
FIG.16cis a perspective view of the embodiment previously depicted inFIG.16ain the delivery configuration.
FIG.16dis an upper view of the lysing tip inFIG.16aand the distal portion of the cannulas.
FIG.16eis a perspective view of the lysing tip of the embodiment previously depicted inFIG.16a.
FIG.16fis an upper view of the lysing tip of the embodiment previously depicted inFIG.16a.
FIG.16gis a perspective view of the lysing tip of the embodiment previously depicted inFIG.16a.
FIG.16his a rear view of the beads and wiring of the embodiment previously depicted inFIG.16a.
FIG.17ais an upper plan view of an embodiment of a lysing tip.
FIG.17bis a cross sectional view of the embodiment previously depicted inFIG.17aat the location shown inFIG.17a.
FIG.17cis an upper plan view of yet another embodiment of a lysing tip.
FIG.17dis an upper plan view of still another embodiment of a lysing tip.
FIG.17eis a perspective view of the structural member coupled with lysing rod.
FIG.17fis a partial breakaway view of the delivery of lysing tip and grasping/control instrument inside a body, said lysing tip to be received and held by a second instrument until the grasping/control instrument grasps and controls lysing tip for the surgical procedure.
FIG.17gis a perspective view of the interaction between a lysing tip, its grasping/control instrument, and a temporary holding/grasping instrument.
FIG.17his a side view of a lysing tip and its associated grasping control instrument without a non-conductive sheath.
FIG.17iis a side view of a lysing tip and its associated grasping control instrument covered by a non-conductive sheath.
FIG.17jis an upper view of a lysing tip depicting middle beads held via friction fit and protuberances.
FIG.17kis a front view of a lysing tip depicting deformed lysing rod between beads.
FIG.17L is a view of the abdomen depicting the construction of a surgical device to be used therein.
FIG.17mis a top plan view of a modular lysing tip depicting internal components of a locking mechanism.
FIG.18ais a perspective view of a system comprising a lysing tip and grasping/control instrument, coupled.
FIG.18bis an upper plan view of a lysing tip and grasping control instrument, coupled.
FIG.18cis a perspective view of a lysing tip and grasping/control instrument, uncoupled.
FIG.18dis a side view of an outer bead, being the inside view of the outer bead.
FIG.18eis a side view of an outer bead, being the outside view of the outer bead.
FIG.19ais an upper plan view of a lysing tip comprising a tab.
FIG.19bis a side view of a grasping control instrument configured to couple with the lysing tip inFIG.19a.
FIG.19cis top view of the lysing tip of the embodiment ofFIG.19acoupled with an energy strip.
FIG.19dis front view of the lysing tip of the embodiment ofFIG.19acoupled with an energy strip.
FIG.20ais a perspective view of system comprising a lysing tip comprising two outer beads and configured to be used with a corresponding grasping/control instrument that defines a third inner bead when coupled.
FIG.20bis a perspective view of the embodiment inFIG.20a, with lysing tip uncoupled from its corresponding grasping/control instrument.
FIG.20cis an upper plan view of the embodiment ofFIG.20a, with lysing tip and its corresponding grasping/control instrument.
FIG.20dis a perspective view of the embodiment ofFIG.20aof the lysing plate and its associated side beads.
FIG.20eis a side view of the embodiment ofFIG.20aof the lysing tip illustrating the positioning of lysing plate within bead.
FIG.20fis an upper view of the embodiment ofFIG.20aof the lysing plate and associated side beads.
FIG.20gis a front view of the embodiment ofFIG.20aof lysing plate and associated side beads.
FIG.20his an upper view of the embodiment ofFIG.20aof lysing plate.
FIG.20iis a perspective view of an alternative embodiment to the device depicted in ofFIG.20ain which the lysing member comprises a circular cross section.
FIG.20jis a side view of a bead from the embodiment ofFIG.20idepicting a hole that makes contact with lysing member and a rod tunnel that does not extend through bead.
FIG.20kis a side view of a bead from the embodiment ofFIG.20idepicting a hole that makes contact with lysing member and a rod tunnel that does extend through bead.
FIG.20L is a top view of the lysing tip ofFIG.20icomprising only a rod and beads.
FIG.20mis a top view of the lysing tip ofFIG.20icomprising a spacer and beads.
FIG.20nis a top view of the lysing tip ofFIG.20icomprising a rod, partial spacer and beads.
FIG.20ois a side view of a grasping control instrument depicted inFIG.20iwith a modified distal jaw shape comprising an overbite shape.
FIG.21ais a perspective view of an alternative embodiment of a system comprising a 2-bulb lysing tip and its associated grasping/control instrument, coupled.
FIG.21bis a perspective view of the lysing tip and its associated grasping/control instrument, uncoupled.
FIG.21cis a side view of the embodiment depicted inFIG.21a.
FIG.21dis an upper plan view of a lysing tip coupled with a grasping/control instrument depicting hidden lines of internal components of a bead on one side.
FIG.21eis an upper exploded view showing beads removed from lysing segment.
FIG.22ais a perspective view of an alternative embodiment of a system comprising a 2-bulb lysing tip with beads rounded on the proximal ends and its associated grasping/control instrument, coupled.
FIG.22bis a perspective view of the lysing tip and its associated grasping/control instrument, uncoupled.
FIG.22cis a side view of the embodiment depicted inFIG.22a.
FIG.22dis an upper plan view of a lysing tip coupled with a grasping/control instrument.
FIG.22eis an upper exploded view showing beads removed from lysing segment.
FIG.23ais an upper plan view of an alternative embodiment of a system comprising a 2-bulb lysing tip illustrating use of cords for retrieval.
FIG.23bis a side view of the embodiment depicted inFIG.23aof the lysing tip and its associated grasping/control instrument, uncoupled.
FIG.23cis a perspective view of the embodiment depicted inFIG.23a.
FIG.23dis an upper view of the grasping plate and lysing member of the embodiment depicted inFIG.23a.
FIG.24ais a perspective view of a lysing tip configured to couple with an electrosurgical pencil.
FIG.24bis an upper view of the lysing tip ofFIG.24acoupled to an electrosurgical pencil.
FIG.24cis a perspective view of an alternative lysing tip configured to couple to an electrosurgical pencil.
FIG.25ais a perspective view of an embodiment of a system for delivery of a lysing tip through a single cannula via a grasping/control instrument further comprising a tether.
FIG.25bis a close-up side view of the embodiment depicted inFIG.25aof the distal end of the embodiment previously depicted inFIG.25awherein the tip is coupled to the instrument tip.
FIG.25cis a close-up side view of the embodiment depicted inFIG.25aof the distal end of the grasping/control instrument of the embodiment previously depicted inFIG.25a.
FIG.25dis a close-up, cross-sectional side view of the distal end of the embodiment previously depicted inFIG.25awherein the tip is coupled to the instrument tip.
FIG.25eis a close-up perspective view of the distal end of the embodiment previously depicted inFIG.25awherein the tip is uncoupled from the instrument tip yet tethered and may contain magnets.
FIG.26ais an elevated view of a lysing tip comprising a non-axial configuration in which the middle spacer is removed.
FIG.26bis an elevated view of a lysing tip comprising a non-axial configuration in which the middle spacer is present.
FIG.27ais an upper plan perspective view of an alternative embodiment for a lysing tip comprising beads with associated sleeves.
FIG.27bis a perspective view of a lysing tip showing two beads removed to expose internal components.
FIG.27cis an upper plan view showing two beads removed to expose internal components.
FIG.27dis the exploded perspective view of one end of a lysing tip to show how a bead is coupled with a lysing rod.
FIG.27eis a perspective view of a side bead.
FIG.27fare perspective views of an outer sleeve illustrating the two ends of the sleeve.
FIG.27gis a side view of an outer bead.
FIG.27his a side perspective view of a middle bead coupled to lysing rod.
FIG.27iis the exploded perspective view of a middle bead to show how a bead is coupled with a lysing rod and sleeve.
FIG.27jis a perspective view of an outer sleeve illustrating the outer tunnel being tapered.
FIG.28ais an upper plan perspective view of an alternative embodiment for a lysing tip.
FIG.28bis an upper view of the lysing tip of the embodiment ofFIG.28a.
FIG.28cis a distal view of the embodiment ofFIG.28a.
FIG.28dis side view of the lysing tip of the embodiment ofFIG.28a.
FIG.28eis a perspective view of a side bead of the embodiment ofFIG.28a.
FIG.28fis a side view of the annular bead of the embodiment ofFIG.28a.
FIG.28gis an upper view of a side bead coupled to lysing rod.
FIG.28his the exploded perspective view of a side bead to show how a bead is coupled with a lysing rod and sleeve.
FIG.28iis a side perspective view of a middle bead coupled to lysing rod.
FIG.28jis a side view of a middle bead.
FIG.28kis an upper view of a middle bead coupled to lysing rod.
FIG.28L is a perspective exploded view of a bead and corresponding sleeve coupled to lysing rod.
FIG.29ais an upper plan perspective view of an alternative embodiment for a lysing tip.
FIG.29bis an upper view of the lysing tip of the embodiment ofFIG.29a.
FIG.29cis a side view of the embodiment ofFIG.29a.
FIG.29dis side view of the middle bead of the embodiment ofFIG.29a.
FIG.29eis a perspective view of the lysing rod and its components with2 beads removed to expose internal components.
FIG.29fis a perspective exploded view of an outer annular bead of the embodiment ofFIG.29ademonstrating how it is coupled with lysing rod and sleeve.
FIG.30ais an upper plan perspective view of an alternative embodiment for a lysing tip.
FIG.30bis an upper view of the lysing tip of the embodiment ofFIG.30a.
FIG.30cis a side view of the embodiment ofFIG.30a.
FIG.30dis side view of the middle bead of the embodiment ofFIG.30aand corresponding sleeve coupled to lysing rod.
FIG.30eis a perspective view of an outer bead in an uncompressed state.
FIG.30fis a perspective view of an outer bead in a compressed state.
FIG.30gis a perspective view of an outer sleeve of the embodiment ofFIG.30a.
FIG.30his a side view of an outer bead in an uncompressed state.
FIG.30iis a side view of an outer bead in a compressed state.
FIG.30jis an upper view of an outer bead in an uncompressed state.
FIG.30kis an upper view of an outer bead in a compressed state.
FIG.31ais a perspective view of an embodiment of a system for delivery of a lysing tip through a cannula in a treatment configuration.
FIG.31bis a close-up perspective view of the embodiment depicted inFIG.31acomprising the middle beads depicted inFIG.28a.
FIG.31cis a close-up perspective view of the embodiment depicted inFIG.31acomprising the middle beads depicted inFIG.27a.
FIG.31dis a close-up perspective view of the embodiment depicted inFIG.31acomprising the middle beads depicted inFIG.29a.
FIG.31eis a close-up perspective view of the embodiment depicted inFIG.31acomprising the middle beads depicted inFIG.30a.
FIG.32ais a perspective view of an embodiment of a TMT coupled to a cannula with actuating rods and canal in the treatment configuration.
FIG.32bis a perspective view of the embodiment ofFIG.32ain between the treatment and delivery configurations without canal.
FIG.32cis a perspective view of the embodiment ofFIG.32ain the delivery configuration without canal.
FIG.33ais a perspective view of a TMT comprising an energy bar coupled to a grasping/control instrument with energy conduit visible.
FIG.33bis a side view of the embodiment depicted inFIG.33awith TMT uncoupled from grasping/control instrument with energy conduit visible.
FIG.33cis a perspective view of a cover to the TMT depicted inFIG.33a.
FIG.33dis a perspective view of the energy bar and members to the TMT depicted inFIG.33a.
FIG.33eis a perspective view of a TMT and its associated grasping/control instrument and an alternative embodiment of an energy conduit.
FIG.33fis a top plan view of the embodiment depicted inFIG.33adepicting the energy window tip in a delivery configuration and coupled to a modular instrument tip.
FIG.34ais an upper view of a dissector/tissue clamp system in the treatment/dissection configuration.
FIG.34bis an upper view of the dissector/tissue clamp system depicted inFIG.34awith jaws in an intermediate configuration.
FIG.34cis an upper view of the dissector/tissue clamp system depicted inFIG.34awith jaws clamped.
FIG.34dis an upper view of the dissector/tissue clamp system depicted inFIG.34ain the delivery configuration.
FIG.34eis an upper view of the dissector/tissue clamp system depicted inFIG.34awith outer cannula removed.
FIG.34fis an exploded view of the parts of the tip of the embodiment depicted inFIG.34a.
FIG.34gis a rear perspective view of the parts depicted inFIG.34fcoupled.
FIG.34his an example of a bipolar embodiment of the system depicted inFIG.34a.
FIG.34iis an alternative embodiment of the bipolar system depicted inFIG.34h.
FIG.35ais a perspective view of an alternative embodiment of a system comprising a rotatable lysing tip and associated grasping/control instrument and cannula.
FIG.35bis a perspective view of the embodiment ofFIG.35awith lysing tip rotated.
FIG.35cis a close-up side rear view of the lysing tip of the embodiment ofFIG.35awith upper jaw removed.
FIG.35dis the side view of the support member of the embodiment ofFIG.35ashowing the upper and lower projections.
FIG.35eis a perspective view of the upper jaw of the embodiment ofFIG.35a.
FIG.35fis a top view of an alternative to the embodiment ofFIG.35ain a delivery configuration in which the upper and lower protrusions are moved away from the centerline of the support member.
FIG.36ais an alternative embodiment of a lysing tip comprising two outer protrusions extending from a support member and two inner beads positioned along a lysing member.
FIG.36bis an upper plan view of various components of the lysing tip of the embodiment depicted inFIG.36a.
FIG.36cis an upper plan view of the lysing tip of the embodiment depicted inFIG.36a.
FIG.36dis an upper plan view of certain components of the lysing tip of the embodiment depicted inFIG.36a.
FIG.36eis a side view of the embodiment depicted inFIG.36a.
FIG.37ais an alternative embodiment of a lysing tip comprising two beads that may cover the end tips of the support member.
FIG.37bis an upper plan view of certain components of the lysing tip of the embodiment depicted inFIG.37a.
FIG.37cis an upper plan view of the lysing tip of the embodiment depicted inFIG.37a.
FIG.37dis a side view of the side bead of the embodiment depicted inFIG.37a, said view being from the inside.
FIG.37eis a side view of the side bead of the embodiment depicted inFIG.37a, said view being from the outside.
FIG.38ais an upper view of a lysing member with associated beads.
FIG.38bis an exploded upper view of an alternative embodiment to the lysing tip ofFIG.38ain proximity to its modular grasping/control device.
FIG.38cis an upper view of the embodiment ofFIG.38bin the delivery configuration.
FIG.39ais a perspective view of an embodiment comprising a modular tip further comprising a support member that slides through a slot within said modular tip.
FIG.39bis an upper view of the embodiment depicted inFIG.39ain the treatment configuration.
FIG.39cis an upper view of a midline cross section of the embodiment depicted inFIG.39bin the treatment configuration comprising a piston engaging and bracing the support member.
FIG.39dis an upper view of the embodiment depicted inFIG.39ain the delivery configuration depicting an alternative mechanism to brace the support member during a surgical procedure.
FIG.39eis an upper view of the embodiment depicted inFIG.39ain the delivery configuration depicting an alternative mechanism to fix the support member during a surgical procedure.
FIG.40 is a flow chart illustrating one implementation of a method for an energy feedback loop.
FIG.41 is a flow chart illustrating one implementation of a method for separating and modifying tissues.
FIG.42 is a flow chart illustrating one implementation of a method for accessing an organ.
FIG.43 is a flow chart illustrating one implementation of a method for hernia repair.
FIG.44 is a flow chart illustrating one implementation of a method for accessing the central nervous system.
FIG.45 is a flow chart illustrating one implementation of a method for removing tissue from a peripheral nerve.
FIG.46 is a flow chart illustrating one implementation of a method for creating a flap.
FIG.47 is a flow chart illustrating one implementation of a method for creating a graft.
FIG.48 is a flow chart illustrating one implementation of a method for removing tissue/tumor from an organ.
FIG.49 is a flow chart illustrating one implementation of a method for removing an organ.
FIG.50 is a flow chart illustrating one implementation of a method for removing scar and/or fibrotic tissue.
FIG.51 is a flow chart illustrating one implementation of a method for treatment of apocrine glands.
FIG.52 is a flow chart illustrating one implementation of a method for treatment of eccrine glands.
FIG.53 is a flow chart illustrating one implementation of a method for reduction of hair.
FIG.54ais a perspective view of surgical site involving cellulite treatment.
FIG.54bis a perspective view of surgical site involving cellulite treatment.
FIG.55 is a flow chart illustrating one implementation of a method for treatment of cellulite.
FIG.56 is a flow chart illustrating one implementation of a method for face dissection and/or face lifting.
FIG.57 is a flow chart illustrating one implementation of a method for neck dissection and/or neck lifting.
FIG.58 is a flow chart illustrating one implementation of a method for dissection of the brow and/or brow lifting.
FIG.59 is a flow chart illustrating one implementation of a method for creating pockets for implants.
FIG.60 is a flow chart illustrating one implementation of a method for capsulotomy.
FIG.61 is a flow chart illustrating one implementation of a method for body lifting and skin excision.
DETAILED DESCRIPTIONFurther details regarding various embodiments will now be provided with reference to the drawings.
FIGS.1a-jdepict an embodiment of aCDTD100 comprising a plurality ofprotrusions101 andrecessions102 positioned in between adjacent protrusions. In the depicted embodiment,recessions102 comprise lysingsegments103a,103b, and103c. Thus, a lysing segment is positioned in each of therecessions102 positioned in-betweenadjacent protrusions101. In the depicted embodiment, these three lysingsegments103a,103b, and103care collectively defined by a lysingmember103. However, other embodiments are contemplated in which separate lysing members may be used for each of the lysing segments positioned between adjacent protrusions.
In this embodiment, the lysingmember103 comprises a lysing plate. However, other embodiments are contemplated in which separate lysing members may be used for each of the lysingsegments103a/103b/103cpositioned betweenadjacent protrusions101.
In the depicted embodiment, thecannulas131 and132 may comprise hollow tubes, which may comprise insulating and/or supportive coating(s) and/or cover overlying other conductive materials. The first/inner/device cannula131 may be considered a device cannula that is coupled with device/lysingtip110 and may or may not be used with a second/outer cannula. The second/outer cannula132 could be associated with a trocar and may be used primarily for surgical introduction of first/inner/device cannula131 into body. In alternative embodiments and implementations even first/inner/device cannula131 may be omitted for certain procedures. With respect to such embodiments, other structural elements may be added to provide rigidity and/or to assist with delivery and/or use of the device during a procedure.
It should be understood that in some embodiments or implementations, such devices can be used in connection with only a single cannula as shown inFIG.1j. Such an embodiment or implementation may be useful because: (A) the surgeon may not be working in a closed cavity that requires insufflation (for example, skin, fat, muscle); (B) it may allow the manufacture of a larger tip configuration than the smallest cannula's constraining dimensions allowing for larger, thicker, stronger components than would otherwise be permitted to fit in the smaller volume or pass through a smaller cross-sectional area, or (C) it may allow smaller diameter entrance incision/wound as cannulas have a thickness component.
Each of theprotrusions101 extends from acommon base105 such that theprotrusions101 are coupled with one another. In some embodiments, each of theprotrusions101 is integrally coupled with each of theother protrusions101. Thus, in some embodiments, each of the protrusions may be defined bybase105. Alternatively,separate protrusions101 may be coupled with or formed onbase105. A linkingmember115 may be an integral part of or a monolithic component with lysingmember103. Alternatively, linkingmember115 could be coupled to the lysingmember103. Linkingmember115 may be used to facilitate a desired coupling between lysingtip110—which, in the embodiment ofFIG.1e, comprisesprotrusions101,recessions102, lysing member(s)103 (which may comprised of lysingsegments103a/103b/103c), linkingmember115, and hinges116/117 that may adhered to or otherwise coupled with linkingmember115—and one or more elements used to facilitate delivery and/or deployment of lysingtip110 throughcannulas131 and/or132 such asactuation rods121,122,123, and/or124. In some embodiments, linkingmember115 may be a separate component from lysingtip110 and may be used to couple lysingtip110 to a hinge and/or actuation rod. Linkingmember115 preferably is at least partially covered and in some embodiments fully covered by an insulating material so that the electrosurgical energy is delivered to lysingmember103 without delivering electrosurgical energy to the rear of lysingtip110. In alternative embodiments, a wire or wires may extend through an insulator or insulating portion of linkingmember115 and connect with a conducting portion of linkingmember115 and/or lysingmember103. This wire or wires could extend through or along one or both of the actuation rods and/or within the first/inner/device cannula131 to supply electrosurgical energy to linkingmember115 from the hand assembly.
In some embodiments and implementations, linkingmember115 may be non-conductive and assuch hinges116 and117 may be electrically coupled to lysingmember103. Alternatively, hinges116 and117 may be non-conductive as well, and in such case, the lysingmember103 may be electrically coupled to electrosurgical energy source by other means such as wire for example.
Retraction guide125 is preferably neartip110 at or near the distal end of one ofactuation rods121/122. In the depicted embodiment,retraction guide125 is positioned near the distal end ofactuation rod122 adjacent to (immediately proximal of)tip110. In some embodiments,retraction guide125 may comprise a resilient material, such as a spring, so that it provides a restorative force during retraction oftip110 intocannula131. Preferably,retraction guide125 is positioned and configured so as to extend fromactuation rod122 laterally by a distance at least approximately equal to, in some embodiments slightly greater than, the distance one or more of theprotrusions101 that extend laterally relative toactuation rod122 in the retracted/folded configuration. In some embodiments,retraction guide125 may extend in this direction a distance equal to, or slightly greater than, the largest protrusion101 (in embodiments in which each of the protrusions are not identical and/or do not project an equal distance).
In the depicted embodiment,protrusions101 are fixed with respect tobase105 and the rest of lysingtip110. In this embodiment,protrusions101 are fixed three-dimensionally with respect tobase105 and the rest of lysingtip110. In other embodiments discussed later,protrusions101 may not be coupled to a common base. Similarly, in other embodiments discussed later,protrusions101 may be movable rather than fixed three-dimensionally. For example, in some embodiments,protrusions101 may be rotatable with respect to a lysing member, a base, and/or another portion of lysingtip110.
System100 may be configured to allow for repositioning of lysingtip110 between a delivery configuration and a treatment configuration. In the delivery configuration,protrusions101 may be configured to extend in a direction that is at least substantially perpendicular to the cannula axis, and lysingtip110 may be configured to extend in a direction that is at least substantially parallel to the cannula axis. In other embodiments, lysingtip110 may be configured to extend at an acute angle relative to the cannula axis so long as the axis of lysingtip110 fits within the lumen of the cannula such as shown inFIG.11fas an example. In addition, in the depicted embodiment, lysingtip110 may be configured such that an energy delivery side of lysingtip110 in front ofprotrusions101 andrecessions102, which energy delivery side will ultimately deliver electrosurgical energy for dissecting tissue, faces an interior surface of a lumen of first/inner/device cannula131 through which lysingtip110 is delivered. Following delivery of lysingtip110 through a distal end of first/inner/device cannula131 and/or second/outer cannula132,system100 may be configured to reposition lysingtip110 to the treatment configuration in which the energy delivery side extends at least substantially perpendicular to the cannula axis.
Lysingtip110 may comprise an orientational-deployment side opposite from the energy delivery side. The orientational-deployment side of lysingtip110 may be configured to allow lysingtip110 to be repositioned between the delivery configuration and the treatment configuration described above. A deployment assembly may be coupled with the orientational-deployment side of lysingtip110. This deployment assembly may be configured to allow for selective repositioning between the delivery and treatment configurations. In the depicted embodiment, the deployment assembly may comprise linkingmember115 and one or more pivot members, such aspivot members116 and117.Pivot members116 and/or117 may comprise various elements configured to allow for selective pivoting, rotation, and/or angulation of lysingtip110, such as joints, ball pivots, hinges, pins, groove/slot pairs, etc.
Pivot members116 and117 may be coupled with linkingmember115 at one end and may be coupled with distal (to the surgeon)portions121 and122 of actuation rods, respectively. Thus, upon advancing one or both ofproximal actuation rods123 and124, lysingtip110 may be advanced in its delivery configuration down one or more cannulas, such as first/inner/device cannula131 and/or second/outer cannula132. In some embodiments, appropriate wires or other transmission lines for delivery of electrosurgical energy may be positioned to extend adjacent and/or through one or more of the various actuation rods. Alternatively, in some embodiments, electrosurgical energy may be delivered directly through one or more actuation rods. In some embodiments, wires or other transmission lines for delivery of electrosurgical energy may instead, or additionally, extend though other regions of lumens of first/inner/device cannula131 and/or second/outer cannula132.Actuation rods121,122,123 and/or124 may comprise any suitable material depending on whether electrosurgical energy is being delivered through them. For example, a metal or other conductive material may be used if electrosurgical energy is to be delivered through the actuation rods, or a plastic or other insulating material may be used if electrosurgical energy is to be delivered through separate wiring or other suitable transmission lines. Actuation rods may be divided into more segments, with or without pivots, than proximal or distal, for example, 3 segments. In some embodiments, actuation rods may be insulated with a non-conductive material but may have a conductive core for delivery of electrosurgical energy.
In this embodiment, spot coagulator (“SC”) is comprised ofSC shaft142 andSC tip141 may be seen in the deployed view.SC shaft142 may be comprised of a metal insulated with a non-conductor. In the depicted embodiment,SC shaft142 is slidably coupled to the first/inner/device cannula131. The more distal end of the SC is theSC tip141 and the more proximal (toward the surgeon) end of the SC isSC shaft142. In this depicted embodiment theSC tip141 extends from theSC shaft142 and is conductive and not insulated along at least a portion of the tip. In some embodiments, the entire tip may be conductive. A spot coagulator may be helpful by allowing the surgeon not to exchange other instruments during the operative procedure to stem bleeding blood vessel(s); it may be beneficial during some surgical procedures to have spot coagulator coagulation capabilities within the same instrument. In the depicted embodiment theSC tip141 may be restricted to 25 mm protrusion beyond the distalmost portion of lysingtip110, which may comprise one end of theprotrusions101 on lysingtip110. In various contemplated embodiments, a bend in theSC shaft142 and/or size mismatch and/or tether, etc., may also be used to limit thedistance SC tip141 may protrude. In other contemplated embodiments, no elements may restrict the working movement range of theSC shaft142. TheSC shaft142 may derive its electrical energy from separate wiring and/or parasitization off of one or more of the actuation rods. In the depicted embodiment,SC shaft142 may comprise one or more non-insulated area(s) that may be brought into an actuation rod or other energetic source within the first/inner/device cannula131. An implementation using the depicted embodiment may involve pushing distally SC either directly or indirectly on theSC shaft142 distally (possibly via through handle assembly160). Electrosurgical energy, such as suitable electrosurgical waveform, may be delivered when the electrosurgical generator is activated, via thehandle assembly160 into theSC shaft142 and thereupon toSC tip141 and then into target tissue. In the depictedembodiment SC shaft142 may comprise stainless steel and may be round in cross-section. Also in the depicted embodiment, the exterior of theSC shaft142 may be insulated. The electrical insulator may comprise, for example, porcelain, ceramics, glass-ceramics, plastics, various halogenated carbon molecules, polytetrafluoroethylene, carbon, graphite, and graphite-fiberglass composites and the like. In some embodiments, the conductive material may comprise: steel, nickel, alloys, palladium, gold, tungsten, silver, copper, platinum and/or any other conductive metal that does not give off toxic residua at operating temperatures. In other contemplated embodiments, the conductive material may comprise cermets and the like. In the depicted embodiment,SC tip141 is shaped like a sphere. In other embodiments, the SC tip may be shaped like the frustum of a cone, pyramid, polyhedron, ellipsoid, as well as a wide variety of geometric shapes. In some embodiments,SC shaft142 may be oval, flat, rectangular or geometric in cross-section or substantially flattened. In alternative embodiments,SC tip141 may be pointed, bullet shaped, or geometric in cross section; more angulate and/or pointed tips may disperse electrical energy more readily and allow greater precision than larger, more rounded tip designs. In the depicted embodiments of theSC shaft142, the electrical insulator may comprise polytetrafluoroethylene. In alternative embodiments the electrical insulator may comprise, for example, polyether etherketone and/or polysulfone and/or another electrically nonconductive polymers (with thermal stability in the operating range) and/or materials that are both electrically non-conductive and of low thermal conductivity. In contemplated embodiments the electrical insulator may comprise, for example, porcelain, ceramics, glass-ceramics, plastics, various halogenated carbon molecules, polytetrafluoroethylene, carbon, graphite, and graphite-fiberglass composites and the like. Although the depicted embodiment shows a manually deployed SC, other contemplated embodiments may allow deployment to be (including but not limited to): motorized and/or spring activated and/or screw driven and/or ratchet style and/or cog style and/or pneumatic and/or hydraulic, etc. In the depicted embodiment, theSC tip141 andSC shaft142 together may measure about, 2 mm in diameter and be of a suitable length to match the given system including the handle assembly. In some embodiments, the insulation thickness may range from about 0.1 mm to 3 mm. Embodiments are contemplated wherein sizes of about one-fifth to about five times these dimensions may have possible uses. It is also contemplated in some veterinary embodiments tip sizes of about one-tenth to 20 times the aforementioned dimensions having possible uses.
System100 comprises two separate cannulas, namely, a first/inner/device cannula131 which preferably comprises a lumen of sufficient diameter to allow folded lysing tip110 (in a delivery configuration) to be positioned within the lumen of first/inner/device cannula131, and a second/outer cannula132, which may have a larger cross-sectional diameter; the first/inner/device cannula131 may be delivered within second/outer cannula132.
In some embodiments and implementations, lysingtip110 may be configured such that itsprotrusions101 and/or another portion of lysingtip110 are too large to fit within the lumen of first/inner/device cannula131, even in the delivery configuration. Thus, lysingtip110 in its delivery configuration may be positioned just outside (immediately distal) of first/inner/device cannula131 and withinsecond cannula132 during delivery and retraction. Any of the embodiments described herein may be configured such that thetip110 cannot be fully received within first/inner/device cannula131. This embodiment may be useful because it permits the tip to be as large as possible given the dimension constraints of the second/outer cannula and not the first/inner/device cannula thus reducing the expense of further miniaturizing and/or allows for thicker/stronger components.
By providing two co-axial cannulas,proximal actuation rods123 and124 may be prevented, or at least substantially prevented, from inordinate bending and/or being separated from one another or otherwisesystem100 may be configured to maintain better control over lysingtip110 during deployment. Thus, preferably,actuation rods123 and124 are also delivered through first/inner/device cannula131. Some embodiments may further comprise one or more additional joints and/or pivot members positioned proximally relative to pivotmembers116 and117. For example, some such embodiments may comprise hinges and/or pivot members that are positioned within one or both ofproximal actuation rods123/124, and one or bothdistal actuation rods121/122 such ashinges127 and128.Hinges127/128 may allow for one or both ofdistal actuation rods121/122 to be pivoted/rotated in a desired direction once hinges127/128 have exited or are approximately coincident with or near the terminal end of first/inner/device cannula131.
In the depicted embodiment, hinge127 may be actuated by providing actuating means comprising twocords129aand129bthat extend fromactuation rod121.Cords129aand129bmay be coupled with lysingtip110 such that forces fromcords129aand129bmay be transferred to lysingtip110 to result in pivoting ofhinge127. By selectively pulling on one of thecords129aand129b,tip110 may be rotated in a desired direction and by selectively pulling on another of thecords129aand129b,tip110 may be rotated in a different desired direction. Of course, any number of cords may be used to fine tune the pivotability of lysingtip110 as desired.Cords129aand129bmay comprise any suitable material, such as wiring, plastic, metal, string, biopolymer, etc.Cord attachment areas121uand121L ondistal actuation rod121 may be used to affixcords129aand129b. Such cord attachment areas may comprise an opening for insertion of the cord which may include a plug or weld to secure the cord. In other embodiments, thecord attachment area121uor121L may comprise a weld against the surface ofdistal actuation rod121.
The deployment assembly ofsystem100 may further comprise ahandle assembly160 that may be used to selectively deploy lysingtip110 and control various aspects of its delivery and/or use during surgery.Handle assembly160 comprises abody161 coupled with apistol grip162. First/inner/device cannula131 may extend from and be coupled withhandle assembly160. Arocker assembly165 or another such control means may be provided for actuation of various features/functions/elements insystem100. For example,rocker assembly165 may be coupled withcords126a/126band129a/129bsuch that, upon pressingrocker assembly165 along a top portion of the assembly, a first cord or set ofcords126band129bmay be pulled causing thetip110 to rotate upwards. Similarly,rocker assembly165 may be further configured such that, upon pressingrocker assembly165 along a bottom portion of the assembly the other cord or set ofcords126aand129amay be pulled causing the tip to rotate downwards. Upon pushing one ofcords126a/129a, the other ofcords126b/129bmay be moved in an opposite direction, since pushing one end ofrocker assembly165 may result in an opposite movement of the opposite end ofrocker assembly165. In this manner, lysingtip110 may be selectively moved in one direction or another as desired. In an alternative embodiment, a more rigid cord or wire may be used to push an actuation rod into a desired position.
In this particular embodiment, hinges127 and128 may be positioned between or at the ends ofactuation rods121/123 and/or122/124, respectively, and may allow for rotation of lysingtip110 above and/or below the cross-sectional profile of first/inner/device cannula131. Alternatively, hinges127 and128 or other means for facilitating movement of the tip outside of the cross-sectional profile of the first/inner/device cannula131 may be positioned along the length of one or more actuation rods such as123 or124 in which case distal actuation rods may be omitted.
Anelectrosurgical actuation button167 may be provided, which a surgeon may use to initiate transmission of electrosurgical energy to lysingtip110. More particularly,electrosurgical actuation button167 may be used to initiate transmission of electrosurgical cutting or blended energy to lysing member/plate103.Button167 may be positioned onrocker assembly165 if desired, as shown inFIG.1i. Pressing or otherwise actuation ofbutton167 may result in delivery of such energy from an electrosurgical generator coupled withhandle assembly160.Handle assembly160 may also be used in connection with any of the other embodiments disclosed herein.
Lysingmember103 is shown removed from the rest of lysingtip110 inFIGS.1gand1h. As shown inFIG.1h, lysingmember103 may be configured to define three separate lysing segments, as shown in the figure. In other embodiments, however, lysingmember103 may be separated into three distinct and separated segments. This may be useful for certain applications, such as, for example, for embodiments using bipolar electrosurgical energy, such that each separate segment may be activated with electrosurgical energy separately.
Handle assembly160 may further comprise one or more other actuation controls. For example, as also shown inFIG.1i, handleassembly160 may comprise a firstactuation rod control168 and a secondactuation rod control169. In some embodiments, one or both of first and second actuation rod controls168 and169 may comprise a ratchet to allow a surgeon to more precisely control the distance with which lysingtip110 is extended and/or allow for locking lysingtip110 in place with respect to first/inner/device cannula131 and/or second/outer cannula132. In some embodiments, one or both of first and second actuation rod controls168 and169 may have a manual control element, such as a finger control element as shown, or another grip, button, trigger, or other suitable control element. First and second actuation rod controls168/169 may be directly or indirectly connected toproximal actuation rods123/124 to effect movement and positioning of lysingtip110.
In some embodiments, handleassembly160 may be configured to be rotatable with respect to the first/inner/device cannula131 and/or the second/outer cannula132 such that the lysingtip110 may be selectively rotated within a patient's body. In other words,system100 may be configured such that some or all of the elements of the system other than first/inner/device cannula131 and/or second/outer cannula132, or in some embodiments some or all elements within first/inner/device cannula131 and/or second/outer cannula132 (such as, in some embodiments, just lysing tip110), may be selectively rotated fromhandle assembly160 to allow lysingtip110 to be selectively rotated as needed during surgery.
It should be understood thathandle assembly160 may be used in connection with one or more of the other systems disclosed herein. Of course, those of ordinary skill in the art will appreciate that any other handle assembly, gun, or other available control mechanism may also be used, as desired.
Some embodiments may be configured such that lysingtip110 is not aligned with the axis ofcannulas131 or132 in the delivery configuration. More particularly the axis of lysingtip110 may be positioned at an acute angle with respect to the axis ofcannulas131 or132. In other embodiments, lysingtip110 may be configured to extend at an acute angle relative to the cannula axis so long as the axis of lysingtip110 fits within the lumen and/or lumens of one and/or both cannulas.
It should be understood that embodiments are contemplated wherein the dimensions of the tip relative to acannula131 may vary as for example, as shown inFIGS.14kand14L. In other words, the lysingtip110 in the axial deployment configuration may be unable to be received withincannula131 such as shown inFIG.14L or may be unable to be received within an inner cannula of two delivery cannulas as shown inFIG.14k. In embodiments comprising two cannulas, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip can correspond to the larger diameter outer cannula as opposed to being limited to the smaller dimensions of the inner/device cannula. In embodiments comprising a single cannula, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip in its axial/delivery configuration only need to correspond to the size of the entrance incision. With respect to such embodiments, the single cannula may primarily serve to protect and stabilize the control rods and provide rigidity to the assembly. Such embodiments may be useful for cosmetic procedures within the skin, for example, but not limited to, for face lifting and/or cellulite treatment.
Although in the embodiments previously depicted, the protrusions typically extended along an axis of the cannula and were parallel to one another along the lysing tip, other embodiments are contemplated in which non-axial protrusions may instead be provided. In some such embodiments such as those depicted inFIGS.26a/26b, for example, the two outermost protrusions/beads may extend at an angle of between about 60 degree and 90 degrees relative to each other. In some embodiments, adjacent beads/protrusions may be configured to extend relative to each other at an angle between about 20 to 40 degrees. It is contemplated that it may be desirable for some implementations and embodiments to provide, non-axial tips extending in a direction or directions falling within this range in order to, for example, allow a surgeon to effectively perform both a to and fro, and a side-to-side (“windshield wiper”) motion using the CDTD. Such side or non-axial protrusions may be useful to enable a surgeon to avoid entangling the dissector in tissue during one or both such motions.
FIGS.2a-2edepict an alternative embodiment of aCDTD system200 comprising a plurality ofprotrusions201 andrecessions202 positioned in between adjacent protrusions. In the depicted embodiment, a lysing member203 (comprised of lysingsegments203a/203b/203c) is positioned so as to extend inrecessions202 and define a plurality of lysing segments. Thus, a lysingsegment203a/203b/203cis positioned in each of therecessions202 positioned in-betweenadjacent protrusions201. Lysingmember203 is further electrically coupled to linkingmember215.System200 further comprises first/inner/device cannula231 and second/outer cannula232, the first or both which may be used to deliver lysingtip210, as previously mentioned.
Some embodiments may comprise anenergy window206 located proximally to protrusions201. In the depicted embodiment,energy window system206 may compriseelectrode termini206a/206b/206c/206dwhich may be supplied energy from an energy source via conduits (not shown) that may comprise, for example, wires and/or fiber optic filaments and/or the like.Energy window206 may be configured in any manner to accommodate any energy modality, including, but not limited to, laser, intense pulse light, resistive heating, radiant heat, thermochromic, ultrasound, mechanical, and/or microwave.
In some embodiments, each of thevarious electrode termini206a/b/c/dmay comprise separate elements each of which may be coupled with lysingtip210. In such embodiments, it may be preferred to have an electrical conduit such as a wire coupled alongtip210 between eachadjacent termini206a/b/c/d. Alternatively, a ribbon and/or band or other suitable coupling element (not shown) may define or contain each of the various termini. Such coupling elements may be coupled with lysingtip210 in any suitable manner.
System200 only differs fromsystem100 in that it lacks a spot coagulator and possesses an energy window(s).
FIGS.3a-3edepict another alternative embodiment of aCDTD system300 comprising a plurality ofprotrusions301 andrecessions302 positioned in betweenadjacent protrusions301. In the depicted embodiment, a lysingmember303, and its associated lysingsegments303a/303b/303c, is positioned so as to extend inrecessions302 and define a plurality of lysing segments. Thus, a lysing segment is positioned in each of therecessions302 positioned in-betweenadjacent protrusions301.System300 further comprises first/inner/device cannula331 and may comprise second/outer cannula332, which may be used to deliver lysingtip310, as previously mentioned.
System300 only differs fromsystem100 in that it possesses unitary/unhinged actuation rods, a canal, and rotational stop means and thatsystem300 lacks a spot coagulator.
System300 may comprise canal(s)304 which may be positioned to supply one or more fluids to the surgical site around or near lysingtip310 via a port located adjacent to the internal device cannula and/or lysing tip (show inFIG.3aonly).Canal304 may be configured to be extended and withdrawn as needed. In alternative embodiments, other fluids that may pass downcanal304 may include, but not be limited to, cold nitrogen gas, fluorocarbons, etc., which might cool and/or freeze tissue to alter it in a desired fashion.
Most notably,system300 comprises means for fixing the rotational orientation of lysingtip310 with respect to first/inner/device cannula331. In some embodiments the rotational fixing means may also provide proximal support to lysingtip310 during a surgical procedure. More particularly, in the depicted embodiment, this rotational fixing means comprises opposingslots333aand333bformed in the distal end of first/inner/device cannula331, which slots are sized, shaped, and configured to receive at least a portion ofactuation rods323/324 when deployed distally. Other examples of rotational fixing means333a/333binclude hooks, catches, etc. In addition, in another example of a rotational fixing means, corresponding features on the deployment side of lysingtip310 may engage the distal end or special features designed in the distal end of first/inner/device cannula331. In some embodiments, such fixing may also provide direct support restricting proximal movement. In alternative embodiments, rotational fixing means may comprise grooves on the inside of the cannula lumen of raised rails or channels in the material from which cannulas are made; said grooves engage one or both actuation rods for support.
FIG.3dshows how portions of theactuation rods323/324 engage rotational fixing means333a/333b.
FIG.3ais an isometric view depicting how, in the treatment configuration, lysingtip310 extends, at both opposing ends, beyond the cross-sectional profile of first/inner/device cannula331. Also, in this particular embodiment, lysingtip310 is coupled withactuation rods323/324 at points that are greater than the inner diameter of the cross-sectional profile of first/inner/device cannula331 in the treatment configuration.
Retraction guide325 is preferably neartip310 at or near the distal end of one ofactuation rods323/324. In the depicted embodiment,retraction guide325 is positioned near the distal end ofactuation rod324 adjacent to (immediately proximal of) lysingtip310. In some embodiments,retraction guide325 may comprise a spring and/or be made up of a resilient material so that it provides a restorative force during retraction of lysingtip310 into first/inner/device cannula331. Preferablyretraction guide325 may be shaped to (A) if made of a non-resilient material, have a sufficient slope so that the edge closest to the cannula does not have its proximal movement impeded but rather cause a lateral movement of the actuation rods and tip toward the opposite side of the cannula or (B) if made of a resilient material, upon contacting the distal end of the cannula,retraction guide325 deforms in a manner that permits proximal movement and then provides a restorative force that guides the lateral movement of the actuation rods and tip to the opposite side of the cannula. Preferably,retraction guide325 is positioned and configured so as to extend fromactuation rod324 laterally by a distance at least approximately equal to, in some embodiments slightly greater than, the distance one or more of theprotrusions301 that extend laterally relative toactuation rod324 in the retracted/folded configuration. In some embodiments,retraction guide325 may extend in this direction a distance equal to, or slightly greater than, the largest protrusion301 (in embodiments in which each of the protrusions are not identical and/or do not project an equal distance).
In the depicted embodiment, each of theprotrusions301 extends from acommon base305 such that theprotrusions301 are coupled with one another. In some embodiments, each of theprotrusions301 is integrally coupled with each of theother protrusions301. Linkingmember315 may be coupled tobase305 and/or lysingmember303.
It should be understood that embodiments are contemplated wherein the dimensions of the tip relative to acannula331 may vary as for example, as shown inFIGS.14kand14L. In other words, the lysingtip310 in the axial deployment configuration may be unable to be received withincannula331 such as shown inFIG.14L or may be unable to be received within an inner cannula of two delivery cannulas as shown inFIG.14k. In embodiments comprising two cannulas, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip can correspond to the larger diameter outer cannula as opposed to being limited to the smaller dimensions of the inner/device cannula. In embodiments comprising a single cannula, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip in its axial/delivery configuration only need to correspond to the size of the entrance incision required for a certain procedure. For example, plastic surgeons may usually attempt to minimize scarring with minimum entrance incision widths, thus, in treating cellulite, the width of the entrance incision and lysing tip profile using embodiments contemplated herein may be 3 to 6 mm. With respect to such embodiments, the single cannula may primarily serve to protect and stabilize the control rods and provide rigidity to the assembly. Such embodiments may be useful for cosmetic procedures within the skin, for example, but not limited to, for face lifting and/or cellulite treatment.
In the depicted embodiment,347 represents an antenna configured to deliver a signal to a receiver unit. In some embodiments,antenna347 may comprise radiofrequency identification (RFID) TAG. In some embodiments the RFID tag may comprise an RFID transponder. In other embodiments the RFID tag may comprise a passive tag. It should be understood thatantenna347 is not depicted in every one of the other figures; any of the embodiments described herein may comprise one or more such elements. Other embodiments may comprise one or more antenna on any other suitable location on the embodiment, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In embodiments in whichantenna347 comprises an RFID transponder, the RFID transponder may comprise a microchip, such as a microchip having a rewritable memory. In some embodiments, the tag may measure less than a few millimeters. In some embodiments a reader may generate an alternating electromagnetic field which activates the RFID transponder and data may be sent via frequency modulation. In an embodiment, the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range. The position may be related to a 3 dimensional mapping of the subject. In an embodiment the reader may generate an alternating electromagnetic field. In some such embodiments, the alternating electromagnetic field may be in the shortwave (13.56 MHz) or UHF (865-869 MHz) frequency. Examples of potentially useful systems and methods for mapping/tracking a surgical instrument in relation to a patient's body may be found in U.S. Patent Application Publication No. 2007/0225550 titled “System and Method for 3-D Tracking of Surgical Instrument in Relation to Patient Body”, which is hereby incorporated by reference in its entirety.
In some embodiments, a transmission unit may be provided that may generate a high-frequency electromagnetic field configured to be received by an antenna of the RFID tag or another antenna. The antenna may be configured to create an inductive current from the electromagnetic field. This current may activate a circuit of the tag, which may result in transmission of electromagnetic radiation from the tag. In some embodiments, this may be accomplished by modulation of the field created by the transmission unit. The frequency of the electromagnetic radiation emitted by the tag may be distinct from the radiation emitted from the transmission unit. In this manner, it may be possible to identify and distinguish the two signals. In some embodiments, the frequency of the signal from the tag may lie within a range of the frequency of the radiation emitted from the transmission unit. Additional details regarding RFID technology that may be useful in connection with one or more embodiments discussed herein may be found in, for example, U.S. Patent Application Publication No. 2009/0281419 titled “System for Determining the Position of a Medical Instrument,” the entire contents of which are incorporated herein by specific reference.
In other embodiments,antenna347 may comprise a Bluetooth antenna. In such embodiments, multiple corresponding Bluetooth receivers at known locations may be configured to sense signal strengths from theBluetooth antenna347 and triangulate such data in order to localize the signal from theBluetooth antenna347 and thereby locate the lysing tip within a patient's body. Other embodiments may be configured to use angle-based, electronic localization techniques and equipment in order to locate theantenna347. Some such embodiments may comprise use of directional antennas, which may be useful to increase the accuracy of the localization. Still other embodiments may comprise use of other types of hardware and/or signals that may be useful for localization, such as WIFI and cellular signals, for example.
One or more receiver units may be set up to receive the signal from the tag. By evaluating, for example, the strength of the signal at various receiver units, the distances from the various receiver units may be determined. By so determining such distances, a precise location of the lysing tip relative to a patient and/or a particular organ or other surgical site on the patient may be determined. In some embodiments, a display screen with appropriate software may be coupled with the RFID or other localization technology to allow a surgeon to visualize at least an approximate location of the tag/antenna, and therefore the lysing tip, relative to the patient's body.
Some embodiments may be further configured such that data from the antenna(s) may be used in connection with sensor data from the device. For example, some embodiments comprising one ormore sensors348 may be further configured with one or more RFID tags. As such, data from the one or more sensors may be paired or otherwise used in connection with data from the one or more RFID tags or other antennas. For example, some embodiments may be configured to provide information to a surgeon regarding one or more locations on the body from which one or more sensor readings were obtained. In some embodiments, temperature sensors may include thermistors and/or thermocouples. To further illustrate using another example, information regarding tissue temperature may be combined with a location from which such tissue temperature(s) were taken. In this manner, a surgeon may be provided with specific information regarding which locations within a patient's body have already been treated in an effective manner and thus which locations need not receive further treatment using the device.
In some such embodiments, a visual display may be provided comprising an image of the patient's body and/or one or more selected regions of a patient's body. Such a system may be configured so as to provide a visual indication for one or more regions within the image corresponding to regions of the patient's tissue that have been sufficiently treated. For example, a display of a patient's liver may change colors at locations on the display that correspond with regions of the liver that have experienced a sufficient degree of fibrosis or other treatment. Such regions may, in some embodiments, be configured such that pixels corresponding to particular regions only light up after the corresponding tissue in that region reaches a particular threshold temperature.
Such sensor348 may be coupled with an antenna, which may send and/or receive one or more signals to/from a processing unit. Alternatively, or additionally, data from such sensors resulting from tissue and/or fluid analysis using such sensors may be stored locally and transmitted later. As yet another alternative, such a signal may be transmitted following surgery. In such implementations, the signals need not necessarily be transmitted wirelessly. In fact, some embodiments may be configured to store data locally, after which a data module, such as a memory stick, may be removed from the device and uploaded to a separate computer for analysis.
Some embodiments may be configured such that lysingtip310 is not aligned with the axis ofcannulas331 or332 in the delivery configuration. More particularly the axis of lysingtip310 may be positioned at an acute angle with respect to the axis ofcannulas331 or332. In other embodiments, lysingtip310 may be configured to extend at an acute angle relative to the cannula axis so long as the axis of lysingtip310 fits within the lumen and/or lumens of one and/or both cannulas.
FIGS.4a-4hdepict an alternative embodiment of aCDTD system400 comprising a plurality ofprotrusions401 andrecessions402 positioned in between adjacent protrusions. In the depicted embodiment, a lysing member403, comprised of lysingsegments403a/403b, is positioned so as to extend inrecessions402 and define a plurality of lysing segments. Thus, a lysingsegment403a/403bis positioned in each of therecessions402 positioned in-betweenadjacent protrusions401.System400 further comprises first/inner/device cannula431 and second/outer cannula432, the first or both which may be used to deliver lysingtip410, as previously mentioned.
System400 differs fromsystem100 in that it lacks a spot coagulator, is configured for bipolar electrosurgical energy delivery, has 3 protrusions and 2 lysing segments, and has electrically isolated linkingmembers415a/415b.
An external power cord may bring electrosurgical energy from an electrosurgical generator to ahand assembly160, such as that illustrated inFIG.1i, (which is electrically connected) toproximal actuation rods423/424 which are physically and electrically via contact coupled todistal actuation rods421/422 and thus to linkingmembers415a/415b(viapivot members416/417) and thus to their respective electrically conductive lysingsegments403a/403b, mounted in therecessions402 in between protrusions, such asprotrusions401. For example, electrosurgical current (comprised of alternating current adjusted to perform certain functions) may flow from electrosurgical generator viaproximal actuation rod423 todistal actuation rod421 to its physically-connected/electrically-coupled/respective linking member415aand thus to its physically-connected/electrically-coupled/respective electricallyconductive lysing segment403a. The electrosurgical current may then travel into the adjacent/target tissue of the patient via lysingsegment403aand then back into lysingsegment403band may then return to the electrosurgical generator via linkingmember415bviadistal actuation rod422 viaproximal actuation rod424. By virtue of the linkingmembers415a/415bbeing separated and/or insulated from each other, the current may not short circuit within lysingtip410.Retraction guide425 is preferably neartip410 at or near the distal end of one ofactuation rods421/422.
The tip shown in this embodiment has threerelative protrusions401, lysing member403 (and associated lysingsegments403a/403b, pointing along the main axis of the CDTD in treatment mode. In other embodiments, the bipolarCDTD lysing tip410 may have one or more non-axial protrusions and one or more non-axial relative recessions. In some embodiments, the tip may have between 3 and 100 axial and/or non-axial protrusions and/or relative recessions. It should be understood that the number of protrusions need not match the number of lysing elements or recessions. In some embodiments, lysing elements may be located at the termini of conductive elements. In some embodiments, lysing elements may also be made partially or completely of a cermet material. In an embodiment, the modularbipolar CDTD tip410 may measure about 12 to 15 mm in width and/or about 3 mm in thickness. Embodiments are contemplated wherein sizes of about one-fifth to about five times these dimensions may have possible uses. It is also contemplated, for example in some veterinary embodiments, tip sizes of about one-tenth to 20 times the aforementioned dimensions may have possible uses. In some embodiments, wherein electrical insulation and/or polymeric insulating coating is present on such parts, for example, but not limited to, distal and proximal actuation rods and linkingmember portions415a/415b, such insulation may measure about 0.5 mm in thickness; in some contemplated embodiments, the insulation thickness may range from 0.01 mm to 3 mm. In other contemplated embodiments, electroconductive leads may course from an electrosurgical generator via first/inner/device cannula431 to energize various lysing elements located inbipolar CDTD tip410. In some embodiments leads may comprise wires and/or conductive conduits.
FIG.4gis a posterior elevated perspective view of the two bipolar lysing segments of the embodiment depicted inFIG.4a. In this embodiment, lysing element403 may be comprised of even numbers of oppositely charged (when activated)individual lysing segments403a/403b. In this embodiment, individual bipolarCDTD lysing segments403a/403bmay comprise surgical grade stainless steel positioned within all and/or a portion of one or more pieces of ceramic and/or other thermally resistant, non-conductive housing. In some embodiments, one or more individual lysing elements may comprise electroconductive materials including but not limited to cermets, steel, nickel, alloys, palladium, gold, tungsten, titanium, silver, copper, and/or platinum. In the depicted embodiment, the lysing elements may measure about 2 mm in length, and about 0.5 mm in thickness/diameter. In the depicted embodiment, the axial lysing elements are concave and crescentic in shape. However, in other contemplated embodiments lysing elements may comprise straight and/or convex and/or a variety of shapes.
In some contemplated embodiments there need not be equal numbers of oppositely signed and/or charged individual lysing elements, for example, there may be 3 positive and 2 negative individual lysing elements. Uniformity of flux on activation may be achieved by modifying the size and/or position of lysing elements with respect to each other among other methods known in the art.
The relative static permittivity of some ceramics may range from about 5 to 10; this may cause some leakage of current in an undesirable path between closely approximated opposing electrodes during activation. Use of other materials, for example, those having over of relative static permittivities of 5 may undesirably alter the resultant plasma field. The relative static permittivity of the intervening materials housing the opposing electrodes may be enhanced by coating and/or surrounding and/or injection molding thermoresistant polymers of a low relative static permittivity into the housing and/or around one or more portions ofbipolar lysing segments403a/403bto reduce the effective static permittivity of the tip. In an embodiment, the thermoresistant polymer of low relative static permittivity 2.1 may be polytetrafluoroethylene. In other contemplated embodiments, thermoresistant polymers may include polyether etherketone (@3.3) and/or polysulfone (@3.1) and the like may be useful.
In the depicted embodiments, the electrical insulator comprises polytetrafluoroethylene. In other contemplated embodiments, the electrical insulator may comprise an electrically nonconductive polymer with a high melting temperature. In some embodiments, the nonconductive polymer may comprise for example, polyether etherketone and/or polysulfone, etc. In other contemplated embodiments, the electrical insulator may comprise an electrically nonconductive and/or thermally nonconductive polymer.
It should be understood that embodiments are contemplated wherein the dimensions of the tip relative to acannula431 may vary as for example, as shown inFIGS.14kand14L. In other words, the lysingtip410 in the axial deployment configuration may be unable to be received withincannula431 such as shown inFIG.14L or may be unable to be received within an inner cannula of two delivery cannulas as shown inFIG.14k. In embodiments comprising two cannulas, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip can correspond to the larger diameter outer cannula as opposed to being limited to the smaller dimensions of the inner/device cannula. In embodiments comprising a single cannula, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip in its axial/delivery configuration only need to correspond to the size of the entrance incision. With respect to such embodiments, the single cannula may primarily serve to protect and stabilize the control rods and provide rigidity to the assembly. Such embodiments may be useful for cosmetic procedures within the skin, for example, but not limited to, for face lifting and/or cellulite treatment.
As of theyear 2000, the bipolar mode had traditionally been used primarily for coagulation (reference: “The Biomedical Engineering Handbook, Electrosurgical Devices” J Eggleston, W Maltzahn, Ch 81, CRC Press 2000). However, more recent modifications to bipolar electrosurgical outputs may have facilitated the use of bipolar cutting instruments (reference: ValleyLab, Hotline, vol. 4,issue 4 pg. 1), examples of such outputs may include Macrobipolar settings (Reference: ValleyLab ForceTriad Users Guide 2006, chapter/sections: 9-13, 9-16, 9-24).
Some embodiments may be configured such that lysingtip410 is not aligned with the axis ofcannulas431 or432 in the delivery configuration. More particularly the axis of lysingtip410 may be positioned at an acute angle with respect to the axis ofcannulas431 or432. In other embodiments, lysingtip410 may be configured to extend at an acute angle relative to the cannula axis so long as the axis of lysingtip410 fits within the lumen and/or lumens of one and/or both cannulas.
FIGS.5a-5edepict still another embodiment of aCDTD system500.FIG.5adepictssystem500 in a treatment configuration.System500 again comprises a plurality ofprotrusions501 and recessions502 positioned in betweenadjacent protrusions501. In the depicted embodiment, a lysingmember503, comprised of lysingsegments503a/503b/503c, is positioned so as to extend in recessions502 and define a plurality of lysing segments. Thus, a lysing segment is positioned in each of the recessions502 positioned in-betweenadjacent protrusions501.System500 further comprises first/inner/device cannula531 and second/outer cannula532, which may be used to deliver lysingtip510 therethrough.
System500 differs from those previously described in thatsystem500 comprises anintermediate hinge member522 that is pivotably coupled at oneend525ato afirst actuation rod521 and pivotably coupled at theopposite end525bto lysingtip510. More particularly,intermediate hinge member522 is pivotably coupled525bat the opposite end tobase505 via linkingmember515. In addition,system500 comprises apivot member523 that is also coupled to lysingtip510, but is coupled to lysingtip510 at a mid-point of lysingtip510 between its opposing ends via linkingmember515.Pivot member523 may also be coupled toactuation rod520.
FIG.5cdepictssystem500 in a delivery configuration with lysingtip510 folded up in alignment with the axis of first/inner/device cannula531 and/or second/outer cannula532.FIG.5bdepicts another perspective view ofsystem500 in an interim position between the treatment configuration and the delivery configuration that depicts the rear or proximal side of lysingtip510. As better seen in this figure, the rear of lysingtip510 comprises acommon base505 from which each of theprotrusions501 extends. Lysingtip510 again comprises a base505 coupled to linkingmember515. In addition, it can be seen fromFIG.5bthat bothintermediate hinge member522 andpivot member523 are coupled to lysingtip base505 via linkingmember515.
Some embodiments may be configured such that lysingtip510 is not aligned with the axis ofcannulas531 or532 in the delivery configuration. More particularly the axis of lysingtip510 may be positioned at an acute angle with respect to the axis ofcannulas531 or532. In other embodiments, lysingtip510 may be configured to extend at an acute angle relative to the cannula axis so long as the axis of lysingtip510 fits within the lumen and/or lumens of one and/or both cannulas.
FIGS.6a-6edepict yet another alternative embodiment of aCDTD system600.FIG.6ais a perspectiveview depicting system600 in a treatment configuration.System600 again comprises a plurality ofprotrusions601 and recessions positioned in betweenadjacent protrusions601. In the depicted embodiment, a lysingmember603 is positioned so as to extend in the recessions and define a plurality of lysingsegments603a/603b/603c. Thus, a lysing segment is positioned in each of the recessions positioned in-betweenadjacent protrusions601.System600 further comprises first/inner/device cannula631 and/or second/outer cannula632, which may be used to deliver lysingtip610 therethrough.
Although, likesystem500,system600 comprises anintermediate hinge member622,system600 differs fromsystem500 in thatsystem600 comprises anintermediate hinge member622 that is pivotably coupled at oneend625ato afirst actuation rod621 but is pivotably coupled at theopposite end625bto a mid-point or near mid-point of lysingtip610 rather than adjacent to an end of lysingtip610. More particularly,intermediate hinge member622 is pivotably coupled to a mid-point or near mid-point ofbase605 via linkingmember615.Pivot member623 may be coupled toactuation rod620.
System600 also differs fromsystem500 in thatpivot member623 is coupled to an end of lysingtip610 rather than to a mid-point of lysingtip610 as insystem500. Because of these pivot/coupling points, lysingtip610 only extends beyond the cross-sectional profile of first/inner/device cannula631 and/or second/outer cannula632 at one end (the end opposite from pivot member623), as shown inFIG.6a.
FIG.6cdepictssystem600 in a delivery configuration with lysingtip610 folded up in alignment with the axis of first/inner/device cannula631.FIG.6bbetter depicts the opposing hinges ofintermediate hinge member622, namely first hinge625aandopposite hinge625b.
FIGS.7a-7fdepict an alternative embodiment of aCDTD system700.System700 comprises a lysingtip710 that is configured to be completely separated from any other element of the system. In this manner, lysingtip710 may be delivered through onecannula732 and then coupled with a grasping/control instrument790 (seeFIG.7f) that may be used to control the lysingtip710 within the body of a patient during a surgical procedure. In some embodiments and implementations, a second cannula, positioned through the same incision or another incision at another site on the patient's body, such as thecannula1735 inFIGS.17f&17g, may be used to deliver a transfer grasping instrument, such astransfer grasping instrument1796 as depicted inFIGS.17fand17g, that may be used to facilitate coupling of lysingtip710 to the grasping/control instrument790, which grasping/control instrument790 may be delivered through thesame cannula732 through which thelysing tip710 is delivered. Alternatively, the lysingtip710 may be delivered though a second cannula along with a transfer grasping instrument used to couple the lysingtip710 to grasping/control instrument790 delivered through thefirst cannula732, which grasping/control instrument790 may be used to control lysingtip710 and perform the surgical procedure. In alternative embodiments, the transfer grasping instrument may comprise at the distal end other means for grasping the lysingtip710 such as a hook and/or magnet and/or glue.
Lysingtip710 may comprise a plurality ofprotrusions comprising bulbs701. A lysingmember703 may be positioned inrecessions702 for delivering electrosurgical energy. Each of the segments of lysingmember703 may be considered lysingsegments703a/703b/703c. In the depicted embodiment, each of the lysing segments is collectively defined by asingle lysing member703. However, other embodiments are contemplated in which separate lysing members may be used for each of the lysing segments positioned between adjacent protrusions.
It should be understood that in some embodiments or implementations,such systems700 can be used in connection without any cannula as shown inFIG.7f. Such an embodiment or implementation may be useful because: (A) the surgeon may not be working in a closed cavity that requires insufflation (for example, skin, fat, muscle); (B) it may allow the manufacture of a larger tip configuration than the smallest cannula's constraining dimensions allowing for larger, thicker, stronger components than would otherwise be permitted to fit in the smaller volume or pass through a smaller cross-sectional area, or (C) it may allow smaller diameter entrance incision/wound as cannulas have a thickness component.
Each of theprotrusions701 extends from acommon base705 such that theprotrusions701 are coupled with one another. In some embodiments, each of theprotrusions701 is integrally coupled with each of theother protrusions701 alongbase705. A linkingmember715 may be coupled tobase705 and/or lysingmember703. In this particular embodiment, linkingmember715 comprises agrasping pad718. The structure ofgrasping pad718 preferably comprises a plate-like shape having opposing surfaces that match or may be grooved to match the jaws of grasping/control instrument790. In the depicted embodiment, the surfaces are flat and define parallel planes.Grasping pad718 may be an integral part of linkingmember715 or be a separate element coupled with linkingmember715.Grasping pad718 may be used to facilitate a desired coupling between lysingtip710—which comprisesprotrusions701,recessions702, lysing member(s)703, and/or linkingmember715 and a grasping/control instrument790 used to control lysingtip710 during a surgical procedure, which instrument may also be delivered throughcannula732.Pad718, in this embodiment, comprises hole718c(shown inFIG.7eonly) which may be used for an alternative means of grasping or otherwise holding the lysingtip710 in position for grasping/control instrument790 to grasp lysingtip710. Such additional means may include threading cord and/or suture and/or wire through the hole or otherwise hooking hole718cor the like. Additionally,hole718h(shown inFIG.7donly) may be used to receive aprojection796a(shown inFIG.7fonly) mounted on the tip of grasping/control instrument to ensure a more stable coupling. In some embodiments, the surface oftab718 may be completely electrically insulated except where contact is made with upper orlower jaw793/794. In alternative embodiments, the entire surfaces ofjaws793/794 and the entire tab may be insulated except withinhole718h(shown inFIG.7d) and atprojection796a(shown inFIG.70 which may serve as a conduit for electrosurgical energy.
Grasping/control instrument790 may comprise means for grasping and/or controlling lysingtip710. “Controlling” herein may be described as including, but not limited to, the physical movement of lysing tip in any direction and/or orientation and the conduction of electrosurgical energy to lysing tip. Such grasping/control instrument790 may comprise grasping means fixedjaw794, grasping means moveableupper jaw793, andshaft791 that may be comprised of additional means to grasp and/or permit the flow of electrosurgical energy to thetip710, such as wires, actuation rods, and the like. In some embodiments, grasping/control instrument790 may further comprise a means for controlling lysingtip710 during a surgical procedure. Grasping/control instrument jaws793/794 may comprise, for example, closable jaws that may be configured to grasp or otherwise engage linkingmember715 viapad718. An actuator (not shown) may be provided for controlling/actuating such jaws, or another means for grasping lysingtip710. Grasping/control instrument790 may be electroconductive in some embodiments such that electrosurgical energy may be delivered throughjaws793/794 to lysingtip710. In some such embodiments, insulation, such as an insulating cover, may be used to cover conductive areas of grasping/control instrument790. In some embodiments, the insulation (if present) on grasping/control instrument790 may extend to at least partially ontojaws793/794 to avoid delivering electrosurgical energy to undesired tissues. In other embodiments, electrosurgical energy may be delivered through another element of the system and, thus, grasping/control instrument jaws793/794 may only be used to physically controltip710 and need not be formed from a conductive material (although still may be if desired).
In some embodiments and implementations, grasping/control instrument790 may be replaced with a device such as second transfer/grasping tip, such astransfer grasping instrument1796 as depicted inFIGS.17fand17g, that may be used to facilitate coupling of lysingtip710. In some such embodiments and/or implementations, the lysingtip710 may be delivered through a separate cannula, which may comprise various elements previously mentioned for delivery of the lysingtip710. Alternatively, the lysingtip710 may be delivered through the same cannula that is ultimately used to grasp and/or control the lysingtip710 during surgery. In other words, the lysingtip710 may be pushed out of the distal end ofcannula732, after which grasping/control instrument790 may be used to grasp or otherwise couple to lysingtip710 and used to perform a surgical procedure.
The embodiment inFIG.7 is similar to the embodiment inFIG.17 in respect that the lysing tip may be passed down the inner cannula and grasped by a second grasping instrument entering the body from another cannula whereupon the second grasping instrument such as a needle driver and/or hemostat and/or clamp and/or the like may grasp the front of a forward portion of the lysing tip andfeed pad718 back into receivingslot797 defined by upper andlower jaws793 and794.
InFIGS.8a-f, asystem800 is depicted which may allow for maintaining control of a free-floating lysing tip and/or facilitating coupling of the free-floating lysing tip with a jaw of a grasping control instrument. Insystem800, atether844 extends through anopening893hformed in ajaw893 of the grasping/control instrument891. Examples of tethers may be cords, bands, wires, sutures or the like. As used herein, “free-floating” lysing tips are lysing tips that are releasably coupled with the instrument(s) that are used to energize and/or control the lysing tips during a surgical procedure. Tether844 may further be configured to be coupled with free-floating, tabbed lysingtip810. In the depicted embodiment, tether844 couples with graspingtab818. More particularly, graspingtab818 comprises anopening818hconfigured to receive thetether844 as shown in the cross-sectional view ofFIG.8d. In some embodiments, theopening818hmay comprise a blind opening. Alternatively, opening818hmay comprise a through-hole. In some embodiments,tether844 may comprise adistal bulb844cand/or stop that preventstether844 from pulling through theopening818h. In the depicted embodiment,bulb844cis configured to be received in arecess818h′ formed in graspingtab818. Recess818h′ may be a portion of opening818hhaving a larger dimension.
In the depicted embodiment, by pulling ontether844 either manually or by way of a mechanism,tip810 may be configured to be directed into thejaws893/894 of grasping/control instrument891. In still other embodiments,tether844 may be coupled withtip810 without also extending through one or both ofjaws893/894. In this manner thetip810 may be retrieved simply by pulling on thetether844. In other embodiments, atether844 may extend through other portions of the grasping instrument, such as thebottom jaw894 and/or bothjaws893/894 and/or through the center of the grasping/control instrument891. The tether may be packaged with a tether already attached or medical personnel at the procedure may choose an appropriate tether to thread and catch in the lysing tip and thread through the jaw with the through-hole.
In some embodiments, one ormore cannulas832 may be used to deliver and/or retrieve lysingtip810. For example,instrument891 and lysingtip810 may be delivered withincannula832. Alternatively,instrument891 and lysingtip810 may be delivered without using a cannula in some embodiments and implementations.
In some embodiments such as that depicted inFIG.8f, one ormore magnets892gon/in one ormore jaws893/894 of graspingcontrol instrument891 may be used to guide lysingtip810 towards a desired location such as withinjaws893/894. In some embodiments, one ormore magnets892tmay be positioned along graspingtab818. In alternative embodiments, one or more magnets may be positioned along graspingtab818 and/or along one or both ofjaws893/894 (892tand892grespectively).
FIG.9 depicts a lysing tip comprising non-axial and/or substantially non-axial protrusions and a proximal tab. In this embodiment, one ormore protrusions901a/901b/901c/901d,recessions902, and/or lysing member(s)903a/903b/903cmay not be in an axial configuration. In all other respects, the lysing tip ofFIG.9 may be similar to that tip depicted inFIGS.7a-7f. In alternative embodiments, the lysing tips may be configured to all point in the same non-axial direction. In still other embodiments, each corresponding protrusion or pair of protrusions may be configured to point in the same direction. In still other embodiments, lysing segments and/or protrusions may be configured to point perpendicular or substantially perpendicular to the axis.
FIGS.10a-10hdepict an embodiment of aCDTD1000 comprising a plurality ofprotrusions1001 comprising the distal tips ofbeads1051, comprisingindividual beads1051a/1051b/1051c/1051d, coupled with one another by way of asingle lysing member1060, in the depicted embodiment, a lysingrod1060, extending throughtunnels1054 extending through each of therespective beads1051a/1051b/1051c/1051d. In this embodiment, lysingrod1060 comprises a lysingrod1060 that defines threeseparate lysing segments1060a/1060b/1060cformed between each bead, and, as described above, may be used to deliver electrosurgical energy during a surgical procedure. Also, like the previously-described embodiments, the areas between each of theadjacent beads1051 may definerecessions1002 positioned in between adjacent protrusions (defined by beads1051). In the depicted embodiment, each of the lysing segments is collectively defined by asingle lysing rod1060. However, other embodiments are contemplated in which separate lysing members may be used for each of the lysing segments positioned between adjacent protrusions.
Beads1051, or any of the other beads described herein, are preferably made from a suitable inert, biocompatible, and non-conductive material, for example, such as a suitable plastic, alumina, zirconia, silicon nitride, silicon carbide, glass, graphite, silicate, diamond, carbon-containing compounds, cermet, or ceramic material or the like, or a combination of one or more of the foregoing.
In the depicted embodiment, lysingrod1060 is positioned throughbeads1051 at a location such thatbeads1051 may be non-symmetrical and/or eccentric relative totunnels1054. In other words, as best shown inFIG.10c,tunnels1054 may be positioned to extend through a non-central location withinbeads1051. Moreover, in the depicted embodiment,beads1051 are non-symmetrical relative to an axis extending through the side-to-side centers of beads1051 (perpendicular to the long axis of the beads). In addition, as shown in the figures, the distal/forward tip ofbeads1051 may have a more narrowed end to act more as a wedge for purposes of acting as a blunt dissector between tissues and tissue planes; the proximal/non-distal/back portions being less narrowed and/or larger in volume may create a desirable drag effect thus orienting the bead in a desirable direction for dissection. Whereas the rear/proximal end ofbeads1051 may take many shapes that may be larger and/or more prominent than that of the front/distal end of the beads. As inFIG.10d, the forward tip may be narrowed by use offacets1052; three are visible and numbered and the fourth is on the opposite side of the one facing the reader. As described later inFIGS.12aa-rr, a wide variety of alternative bead shapes are possible including, for example, ovoid shapes, spherical shapes, wheel shapes, bullet shapes or other shapes having a flat terminal end (such as, for example, frusto-shaped), wing shapes, etc. As can be seen from some of the examples shown inFIGS.12aa-rr, in some embodiments, beads may be symmetrical relative to the openings for receiving the rod. In some embodiments,beads1051 may be faceted on the top, bottom, sides, front and/or back such as illustrated inFIGS.10cand10d, atfacet1052. Facets are preferably formed on the distal/front/leading portions of the bead to facilitate tip movement through/between tissue layers.
In some embodiments, thetunnels1054 may be positioned in a non-central location withinbeads1051. For example, in some preferred embodiments, thetunnels1054 may be positioned in a forward or distal location relative to a central axis ofbeads1051. This may be preferable to allow thelysing tip1010 to be directed through tissue in a desired manner, such as without allowing thebeads1051 to rotate on their respective tunnels in an undue manner. However, some embodiments may be configured to allow a certain amount of such rotation so that the tip can be maneuvered through patient tissue in a flexible manner.
In some alternative embodiments, the forward ordistal portions1001 of beads relative totunnels1054 may also, or alternatively, be wider than such thatbeads1051 have a trailing end that may be longer and/or more narrow, which may yield desired aerodynamics and/or maneuverability; this may be similar to a ‘kite-tail’ effect.
Preferably, the entire surface of the beads may be smooth, however, some faceting features may provide for a surface that is less smooth. For example, providing a smooth front end and a smooth trailing end may allow the lysing tip to be moved in a forward direction and then in a rearward direction back and forth without catching an undesirable amount of tissue on beads to inhibit such movement. However, as mentioned elsewhere in this disclosure, in some embodiments, the trailing end may comprise a flat surface such that the entire bead comprises a frusto-ellipsoidal shape or another similar shape. Preferably, at least the forward or distal surface of the beads is smooth and defines an ellipsoidal shape or another shape having an at least substantially smooth forward surface. In alternative embodiments, various portions of the bead may be textured or given surface irregularities that may yield a desired dissection orientation such as for example having the non-proximal/rear portion of the bead roughened on the surface to create drag from the rear.
In some embodiments, it may be desirable to allowbeads1051 to rotate on lysingrod1060. Thus,beads1051 may not be fixed three-dimensionally with respect to lysingrod1060 and/or one or more other elements of lysingtip1010. In some such embodiments,beads1051 may be at least partially rotatable with respect to theentire lysing tip1010. For example, the beads may rotate about the rod upon encountering tissue similar to that of a vegetable/fruit peeler. In embodiments in whichbeads1051 are rotatable in this manner, it may be desirable to use a lysing rod having a circular cross section. Other embodiments are contemplated in which, instead of being rotatable, the beads may be otherwise movable with respect to one or more elements of alysing tip1010. In any such embodiments, such beads may be considered not three-dimensionally fixed with respect to the lysing rod and/or lysing tip.
In the depicted inFIG.10c,protuberances1065a/1065b/1065c/1065d/1065e/1065fformed on the lysingrod1060 may be created to restrict lateral movement of the beads, and depending upon the distance from a bead, may restrict or partially restrict rotational movement of the beads around the axis of lysingrod1060. In the preferred implementation, a LASER or arc welder may be used to heat the conductive material comprisinglysing rod1060 causing liquefaction that cools into a non-uniform structure that increases an outer diameter measurement of lysingrod1060. Thus, in such embodiments and implementations,protuberances1065a/b/c/dmay comprise “welds” that deform lysingrod1060. In alternative embodiments, “welds” may comprise added material to lysingrod1060 through welding techniques in said locations and may be located at any cross-sectional orientation including facing proximally or distally. In alternative embodiments, crimps that mechanically deform the metal at or substantially adjacent to beads may be utilized to hold beads at particular locations on lysingrod1060. In additional embodiments, lysingrod1060 may be deformed at locations wherebeads1051 are desired and couple at those locations via a friction fit between the bead tunnel and the lysingrod1060.
Although allowing rotation of beads on a lysing rod may be desired for certain surgical procedures, it may be desirable to prevent or at least inhibit such rotation in other embodiments. Thus, in some such embodiments,tunnels1054 and/or the lysingrod1060 may comprise a non-circular shape in cross-section to prevent or at least inhibit such rotation. In alternative embodiments,beads1051 may effectively be welded to the lysingrod1060 as an alternative method to inhibit rotation. Each bead may comprisehole1055 that may be positioned perpendicular to lysingrod hole1054;holes1055 may be available as a platform/location to add other features/components such as providing a location for coupling of a cord as described below in connection with other embodiments and/or locating a sensor and/or RFID location component and/or being used for placement of luminescent and/or light production element(s) for visualization, for example, tritium and the like.
In alternative embodiments,hole1055d′ may be moved to fully or partially intersecttunnel1054 thus allowing communication with lysingrod1060; thus a weld, plug (for example1055p), glue, insert or other method of fixation may be inserted viahole1055d′ to attach to lysingrod1060 thus restricting lateral movement of a bead. To reduce escape of electrosurgical energy throughhole1055d′, an insulator comprised of epoxy, plastic, ceramic or the like may be placed in part or all of the remaininghole1055d′. This alternative embodiment may be applied to other embodiments herein.
In alternative embodiments, the lysing rod may lack coupling tips at its outermost portions. Instead any number ofbead holes1055d′ may be made at any number of angles to intersect the lysingrod1060 and/or itstunnel1054 to deposit a material that restrains the lysing rod within the bead1051 (for example, materials may include welds, glues, epoxies, plugs, and the like). In such embodiments,tunnel1054 may be a blind tunnel not requiring full passage throughbead1051 asbead1051 may be fixed/restrained internally (See for exampleFIGS.20j/kshowing side views ofbeads2051a′ and2051a″.FIG.20kshows full passage oftunnel2054 which intersects withhole2055′ (illustrated with dashedlines designating hole2055′).FIG.20jillustratestunnel2054′ which intersects withhole2055′ (illustrated with dashedlines designating hole2055′) not extending to the outside ofouter bead2051a″ (2054′ illustrated with dashed lines). This feature of this embodiment may be applied to other embodiments herein. Beads may comprisefacets2052.
The shape of lysing member/lysing rod1060 may also be important as to the most efficient and safe means to transfer electrosurgical energy from the lysing rod to the tissue(s). Since electrosurgical energy on/under a surface tends to move toward edges of an object, a lysing rod with a circular cross section may force current to the opposing lysing rod tips and/or protuberances creating hot spots at/near adjacent beads and/or protuberances. Therefore, it may be beneficial for lysingrod1060 to comprise a non-circular cross section with substantially uniform edges along its length from which electrosurgical energy may uniformly be transferred to tissues. In contemplated embodiments, a pentagonal or hexagonal cross-sectional shape may be preferable. In other embodiments, spacers with non-circular cross-sections may accumulate less debris and/or eschar on lysing rod and/or spacer because debris may have a more difficult time adhering to an angled edge when forces are applied to the debris.
As shown inFIG.10b,actuation rods1021 and1022 exit distally from inner/device cannula1031. The distal terminations ofactuation rods1021 and1022 may contain holes in the distal area through which lysingrod1060 may extend.Actuation rods1021/1022 may terminate on the outermost side ofouter beads1051aand1051d. In alternative embodiments,actuation rods1021/1022 may be coupled to the lysingrod1060 between the two outer pairs of beads such as that shown inFIG.17a.
Lysing rod1060 may be held in position by features located on the ends of lysingrod1060, namely couplingtips1063 and1064. Couplingtips1063/1064 may have diameters larger than the inner diameter of theircorresponding holes1026 inactuation rods1021/1022 respectively. The coupling tips may take various shapes. InFIG.10c,coupling tip1063 comprises the shape of a mushroom cap andcoupling tip1064 comprises the shape of a ball. In alternative embodiments, other shapes may be used to couple the ends of lysingrod1060 that effectively prevent lysingrod1060 from sliding through eitherhole1026. Couplingtips1063/1064 may be made by for example by liquefying the ends by LASER and/or other heating and/or other metal modification methods; and in other embodiments, coupling tips may be separate structural elements such as screw-on nuts or the like. In some embodiments, it may be desirable to provide features and/or elements that inhibit or limit the ability of the electrosurgical energy to discharge from the opposing ends of the lysing rod. Thus, in some such embodiments,coupling tips1063/1064 may be coated or covered with a suitable insulating material such as an epoxy with non-conductive properties; this may apply to all embodiments herein.
FIGS.10fand10gdemonstrate how the lysingtip1010 transitions between the delivery and treatment configurations. As shown inFIG.10factuation rod1022 comprises afirst bend1029awhich allows the rear portion ofbead1051ato be received within a widened defined area defined bybend1029ato allow lysingtip1010 to pivot from a treatment configuration to a delivery configuration. As can be seen in this figure, some embodiments may be configured such that lysingtip1010 is not aligned with the axis ofcannulas1031 or1032 in the delivery configuration. More particularly the axis of lysingtip1010 is positioned at an acute angle with respect to the axis ofcannulas1031 or1032. In some embodiments, asecond bend1029bmay be provided at or near the distal end ofactuation rod1022 which second bend may be in the opposite direction offirst bend1029a, As shown inFIG.10g,hole1026 is positioned in the middle ofsecond bend1029b;second bend1029bbeing part ofhole1026 may allow additional rotational movement of lysingrod1060 as it pivots more toward the delivery configuration.
As shown inFIG.10g,opening1026 may be elongated in the direction of or at least substantially in the direction of the axis ofactuation rod1022 such that as lysingtip1010 is repositioned between the treatment and delivery configurations, the portion of lysingrod1060 adjacent tocoupling tip1064 can move/pivot withinopening1026 to allow lysingtip1010 to similarly pivot with respect to the axis ofcannulas1031 and/or1032. The shape ofopening1026 may be oval and/or rectangular or the like. In other words, in the present embodiment, holes1026 may be elongated shapes, for example, in the form of ovals or rectangles that facilitate the folding away of thelysing tip1010 against theactuation rods1021 and1022. In some such embodiments or in alternative embodiments internal beveling around theholes1026 may facilitate movement between treatment and delivery configurations. In some embodiments and implementations such as depicted inFIG.10h, lysingtip1010 may be configured such that itsbeads1051 are too large to fit within the lumen of first/inner/device cannula1031, even in the delivery configuration. Thus, lysingtip1010 in its delivery configuration may be positioned just outside (immediately distal) of first/inner/device cannula1031 but within second/outer cannula1032 during delivery.
In the present embodiment,coupling tips1063/1064 are not the same shape and may be different aspre-formed lysing rods1060 may be delivered to the assembly line with mushroom-style coupling tips at one end, and ball-style coupling tips may be the preferred method to create coupling tips on a production line to fix thebeads1051 and lysingrod1060 into position relative toactuation rods1021/1022.
In the present embodiment,actuation rods1021 and1022 are not comprised of any pivotable hinges but are comprised of bends at various locations along actuating rods to facilitate deployment and control of lysingtip1010. In alternative embodiments, hinges and/or control cords may be placed along the length of actuation rods to facilitate movement in other directions.
FIG.10hdepicts an alternative configuration similar to that ofFIG.10f. However, in the configuration ofFIG.10h, thelysing tip1010 is configured such that it cannot be fully received withincannula1031. In some embodiments and implementations,cannula1031 may comprise an inner cannula in which case an outer cannula (not shown inFIG.10h) may also be used. Preferably, in such configurations thelysing tip1010 may be fully received within the outer cannula in its delivery configuration.
FIG.10eis a topview illustrating system1000 that lysingrod1060 may deform whentip1010 encounters resistance during a surgical procedure. In the figure, thecenter beads1051b/1051care pushed proximally deforminglysing rod1060.
System1000 comprises means for fixing or guiding the ‘rotational orientation’ of lysingtip1010 with respect to first/inner/device cannula1031. In some embodiments the rotational fixing means may also provide proximal support to lysingtip1010 during a surgical procedure. Rotational fixing means1033 is configured to engageactuation rods1021/1022. More particularly, in the depicted embodiment, rotational fixing means1033 comprises opposingslots1033aand1033bformed in the distal end of first/inner/device cannula1031, which slots are sized, shaped, and configured to receive at least a portion ofactuation rods1021/1022 when deployed distally. Other examples of rotational fixing means1033 include hooks, catches, etc. In addition, in another example of a rotational fixing means, corresponding features on the deployment side of lysingtip1010 may engage the distal end or special features designed in the distal end of first/inner/device cannula1031, in someembodiments1033aand/or1033b, and such seating may provide direct support restricting proximal movement and/or fixing the tip against rotation.
Each bead may have a height BH as illustrated inFIG.10dand a length BL extending perpendicular to the axis of the lysingrod1060. Each bead also has a width BW as shown inFIG.10e. Similarly, lysingtip1010 may have a length TL which preferably extends in the same direction as the axis of lysingrod1060 and a tip width TW extending perpendicular to the tip length TL as shown inFIG.10eand a tip height TH as shown inFIG.10d. In some embodiments, the tip height TH may be identical to the bead height BH. However, in other embodiments, the tip height may differ from the bead height.
FIGS.11a-11edepict various views similar to those depicted inFIGS.10a-10hfor an alternative embodiment of aCDTD system1100.System1100 differs fromsystem1000 in thatspacers1162a/1162b/1162cmay be positioned betweenbead pairs1151a/1151b,1151b/1151c, and1151c/1151d.System1100 is comprised of first/inner/device cannula1131 and second/outer cannula1132 through whichlysing tip1110 may be deployed or retrieved viaactuation rods1121 and1122. In the depicted embodiment, each of the respective lysing segments between each bead pair comprises a spacer1162 (1162a/1162b/1162c) that may be configured to space thevarious beads1151 apart, provide stability to the lysing tip, and/or protect the respective lysing segments (which, in the depicted embodiment, are collectively defined by a single lysing member/lysing rod1160). Preferably,spacers1162 comprise a conductive material, such as a suitable biocompatible metal, that can receive electrosurgical energy from the lysingmember1160 and deliver it to various body tissues during a surgical procedure. Preferably, spacer(s)1162 are therefore in direct contact with lysingmember1160. In some embodiments, asingle spacer1162 may both extend between thevarious beads1151 and extend through thetunnels1154 through thebeads1151.Lysing rod1160 terminates on its opposing ends atcoupling tips1163 and1164 that may hold the bead/lysing rod/spacer components in position betweenactuation rods1121 and1122. Each bead may comprisehole1155 that may be positioned perpendicular to lysingrod hole1154;holes1155 may be available as a platform/location to add other features/embodiments and/or to be used for cord/suture attachments for lysing tip manipulation and/or removal and/or be used for placement of luminescent and/or light production for visualization, for example, tritium and the like. Eachbead1151 may comprise one ormore facets1152.
Spacers1162a/1162b/1162cmay be coupled with lysingrod1160 by, for example, slidingspacers1162 comprising a lumen along the axis of lysingrod1160. Alternatively,spacers1162 may be coupled with lysingrod1160 by placingspacers1162 over lysingrod1160 in a direction perpendicular to the axis of the lysing rod at a desired location using a slot or other opening formed along a portion of aperimeter spacer1162. For example, spacers may be provided with a slit extending along their respective axes. Such spacers may then be coupled with a lysing rod by aligning the slit with the lysing rod and pressing the spacer towards the lysing rod to snap it in place. In some embodiments and implementations,spacers1162 may be crimped or otherwise fixedly coupled with lysingrod1160 at a desired location. In some embodiments, this fixed coupling may be configured to prevent the relative movement between lysingrod1160 and spacer1162 possibly reducing hot spots caused from high current density flow in certain areas between lysingrod1160 andspacer1162. These exemplary methods for applying spacers to a lysing rod and/or another lysing member may be apply to any of the other embodiments utilizing spacers.
In some contemplated embodiments spacers may be comprised of insulating materials (such as ceramic, glass, plastic and the like) that may have holes (illustrated inFIG.12j) and/or be porous and/or have breaks and/or have separations such that energy from lysing member(s) within may be released into target tissues.
In some such embodiments,beads1151 may be at least partially rotatable with respect to theentire lysing tip1110. In embodiments in whichbeads1151 are rotatable in this manner, it may be desirable to use a lysing rod having a circular cross section. It may also be desirable to either omitspacers1162 or form them without the beveled edges as shown in12iand12j.
Spacers1162 may be used to prevent rotation ofbeads1151 or to selectively limit the amount of rotation ofbeads1151 on a lysingmember1160. For example, ifspacers1162 extend the entire distance or at least substantially the entire distance between each adjacent bead, spacers may prevent rotation or, depending upon the distance between spacers and adjacent beads, may be used to allow for a predetermined amount of such rotation. Similarly, the opposing ends ofspacers1162 may be shaped to match or at least substantially match the shape of the adjacent bead(s) again to either prevent or control rotation.
The shape of lysing member/lysing rod1160 and/orspacers1162 may also be important so as to provide selective energy-to-tissue delivery. Electrosurgical energy on/under a surface may tend to move toward edges of an object. In some embodiments, therefore, it may be beneficial for lysingrod1160 and/orspacer1162 to comprise a non-circular cross section with acute or substantially acute cross-sectional angles along its perimeter thus creating a lysing rod with edges that may increase electrosurgical energy discharge in those areas. In contemplated embodiments, a pentagonal or hexagonal cross-sectional shape may be preferable. Additionally, spacers with non-circular cross-sections may accumulate less debris and/or eschar on lysing rod and/or spacer because debris may have a more difficult time adhering to an angled edge.
System1100 is otherwise similar tosystem1000. For example,system1100 comprises areas between each of theadjacent beads1151 that definerecessions1102 positioned in between adjacent protrusions1101 (defined by distal/leading portions of beads1151). In addition, lysingrod1160 defines lysing segments that are positioned between each of theadjacent beads1151.
In some embodiments, thetunnels1154 may be shaped and/or sized such that the lysingrod1160 alone can provide the needed rigidity and structure toseparate beads1151 without providing spacers.
In some embodiments and implementations such as depicted inFIG.11f, lysingtip1110 may be configured such that itsbeads1151 are too large to fit within the lumen of first/inner/device cannula1131, even in the delivery configuration. Thus, lysingtip1110 in its delivery configuration may be positioned just outside (immediately distal) of first/inner/device cannula1131 but within second/outer cannula1132 during delivery.
FIGS.12a-12rrdepict 3 general components of the lysing tip and various potential shapes: Lysing rod (FIGS.12a-12g), spacers (FIGS.12h-12t), and beads (FIGS.12aa-12rr).
FIGS.12a-12gdepict various examples of cross-sectional shapes of wires or other lysing members. In some embodiments, these shapes may be formed by crimping a wire or other suitable lysing member into the desired shape. Crimping the lysing member may be particularly useful in connection with certain embodiments and/or implementations of the invention, as it may facilitate a preferred coupling between various other elements of the CDTD system, such as the beads and/or spacers. Crimping may also, or alternatively, be useful in providing for a preferred delivery of electrosurgical energy through the wire/lysing member. Other methods of shaping the lysing member may include but not be limited to cutting, polishing, forging or forming by extrusion. In additional embodiments, various coatings may be applied to lysing rods that may reduce adhesion of heated biological material to the lysing rod or spacers.
FIG.12acomprises a lysing rod having a circular cross-section. The shape of lysing member/lysing rods may also be important as to the most efficient and safe means to transfer electrosurgical energy from the lysing members to the tissue(s). Electrosurgical energy on/under a surface may tend to move toward edges of an object. This shape may be useful for allowing a useful distribution of a coating to the surface of the lysing rod that may be used to reduce char buildup and/or modify ease of movement of a lysing tip through tissue.FIG.12bcomprises a lysing rod having a triangular cross-section; this may be useful for maximizing electrosurgical energy discharge and minimizing char build-up about the lysing rod.FIG.12ccomprises a lysing rod having a square cross-section.FIG.12dcomprises a lysing rod having a pentagonal cross-section along its length whileFIG.12dxcomprises a lysing rod having a pentagonal cross-section that is twisted along its length.FIG.12ecomprises a lysing rod having a hexagonal cross-section.FIG.12fcomprises a lysing rod having a wedge-shaped cross-section.FIG.12gcomprises a lysing rod having a semi-circular or frusto-circular cross-section.
FIGS.12h-12tdepict various shapes for spacers that may be used in connection with one or more of the embodiments disclosed herein. Each may have a hole through which lysing members may extend. As illustrated in these figures,FIG.12hillustrates a spacer having flat ends and a cylindrical shape.FIG.12iillustrates a spacer having a circular cross-section and tapered ends which may be useful for allowing a desired distribution of a coating to the surface of the spacer to reduce char buildup and/or modify ease of movement of a lysing tip through tissue.FIG.12jcomprises various openings, such as holes, for delivery of electrosurgical energy therethrough; this may allow for making spacers of a non-conductive material and still deliver such energy therethrough.FIG.12killustrates an alternative spacer that is arced.FIGS.12L (resting) and12m(stressed) illustrate an alternative spacer having opposing loops with central openings configured to allow for receipt of a wire or other lysing rod therethrough and a flexible connector extending between the two loops. As shown inFIG.12m, once coupled with adjacent beads (not shown), the flexible connector may bend to serve as a brace and space apart the adjacent beads. This spacer may also be configured such that the opposing loops may be flexed to the side to allow for coupling of adjacent beads and receipt of a lysing rod therethrough (not shown).FIG.12nillustrates a cross-sectional view of another spacer having a triangular cross-sectional shape and an opening for receipt of a lysing rod therethrough.FIG.12oillustrates a cross-sectional view of another spacer having a rectangular cross-sectional shape and an opening for receipt of a lysing rod therethrough.FIG.12pillustrates a cross-sectional view of another spacer having a pentagonal cross-sectional shape along its length and an opening for receipt of a lysing rod therethrough whileFIG.12pxcomprises a spacer having a pentagonal cross-section that is twisted along its length and an opening for receipt of a lysing rod therethrough. Spacers with twisted features may acquire less debris along its surface and may tend to rotate thus multiple sides of a spacer are exposed to charred tissue.FIG.12qillustrates a cross-sectional view of another spacer having a hexagonal cross-sectional shape and an opening for receipt of a lysing rod therethrough.FIG.12rillustrates a blade-style cross-sectional shape with smooth, rounded outer surfaces that meet at the distal edge and an opening for receipt of a lysing wire or other lysing rod therethrough.FIG.12sillustrates a cross-sectional view of another spacer having a blade cross-sectional shape (differing fromFIG.12rin that outer surfaces are formed by intersecting planar/flat surfaces) and an opening for receipt of a lysing wire or other lysing rod therethrough.FIG.12tillustrates a cross-sectional view of another spacer having a spindle cross-sectional shape and an opening for receipt of a lysing wire or other lysing rod therethrough.
The cross-sectional shape of the exterior surface of spacers12-4 may also be important as to the most efficient and safe means to transfer electrosurgical energy from spacers to the tissue(s). Electrosurgical energy on/under a surface may tend to move toward edges of an object, so a spacer with an exterior surface having a circular cross section may force current to the opposing spacer ends creating hot spots at/near adjacent beads. Therefore, it may be beneficial for spacers to comprise an exterior surface having a non-circular cross section with one or more substantially uniform edges along its length from which electrosurgical energy may uniformly be transferred to tissues. In contemplated embodiments, a pentagonal or hexagonal cross-sectional shape may be preferable. Additionally, spacers with non-circular cross-sections may accumulate less debris and/or eschar on lysing rod and/or spacer because debris may have a more difficult time adhering to an angled edge. In some embodiments, one or more (in some embodiments, all) of the spacers may comprise a leading edge for delivery of electrosurgical energy from the lysing member(s). In some such embodiments, one or more of the spacers may comprise only a single such leading edge. In some such embodiments, the spacer(s) may comprise a smooth, or at least substantially smooth, exterior surface, other than the single leading edge. For example, the spacer(s) (or, in some embodiments, the lysing member/rod itself) may comprise a circular or oval shape in cross section with a flattened leading end terminating in a leading edge. This may be useful for controlling the delivery of electrosurgical energy.
Because the spacers may be configured to receive the lysing member/rod therethrough, the spacers may also comprise an opening extending therethrough for receiving the lysing member/rod. Thus, the spacers may also have an interior cross-sectional shape, which may differ from the shape of the exterior surface. For example, it may be useful to form the spacers with an opening having a cross-sectional shape that matches the cross-sectional shape of the lysing member/rod. Thus, if the lysing member/rod comprises a circular or polygonal shape in cross-section, the spacer(s) may comprise an opening having a similar cross-sectional shape. In some embodiments, the shape of the exterior surface of the spacers may therefore be used to primarily dictate preferred delivery locations for the electrosurgical energy.
FIGS.12aa-12rrshow 12-5 alternative shapes for beads positioned along a lysing tip. As illustrated in these figures, bead shapes that may be useful may include spheres (FIG.12aa), wheel shapes (FIG.12bb), dodecahedron shapes (FIG.12cc). In other embodiments, bead shapes may be bullet-shaped or partially or substantially ellipsoidal (FIGS.12dd-12ff) and may have facets (FIGS.12eeand12ff). In other contemplated embodiments, beads of various geometries may be cut off having flat or slightly curved proximal surfaces or further shaped by geometric cuts (FIGS.12gg-12LL) (herein, this may be referred to as “frusto-shaped”). In other contemplated embodiments, bead shapes and/or tunnels through them may be uniform spherical and/or centered. In other contemplated embodiments, beads may have skeleton features supported by a hub that may be adjacent to the lysing rod or adjacent to or formed around a ceramic sleeve through which a lysing rod is extended (FIGS.12mm-12rr). 12-6 In some contemplated embodiments, providing a rough trailing end may create frictional drag on that portion of the bead thus helping reorient the front end of the bead for further tissue passage. Thus, in some embodiments, the trailing end may have a rougher surface than the front end. For example, in some embodiments, the trailing end, or at least a portion of the trailing end, of one or more beads may be sanded with a rougher sanding material than the leading end, may be formed with ridges, grooves, or other roughening elements, or may otherwise be made with a less smooth surface for this purpose. In some contemplated embodiments such as that depicted inFIG.12rr, a bead may comprise a slot beginning at its trailing end and terminating within the bead12rrso as to allow for receipt of a lysing rod therein. In some such embodiments, ahole1255 may be positioned to extend through the bead and may at least partially intersect withslot1253. Thus a weld, plug, glue, insert or other method of fixation may be inserted viahole1255 to attach to a lysing rod thus restricting movement of a bead and/or rotation of the bead with respect to its lysing rod.
In alternative embodiments, beads may comprise a conductive material such as metal and coated with an insulator; for example, a bead shaped such asFIG.12rrbut made of metal (internally) may be pressed over a lysing rod with increased pressure closing the slot behind the lysing rod causing the bead to remain in place along a lysing rod.
FIGS.13a-13idepict another embodiment of aCDTD system1300 comprising a plurality ofbeads1351 positioned on lysingmember1360 which comprises lysingplate1360. It should be noted that in the embodiments of13a-13i,beads1351 are supported laterally by lysingplate1360. It should also be noted thatbeads1351 lack a base, such asbase105 forsystem100, and instead define a lysing tip that lacks structure immediately behind the beads for support. It should also be noted that lysingtip1310 comprises beads1351 (1351a/1351b/1351c/1351d) that project both distally and proximally relative to lysingplate1360.
System1300 may be configured to allow for repositioning of lysingtip1310 between a delivery configuration and a treatment configuration. In the delivery configuration, the axis of each of the elongatedbeads1351 towards the treatment side may be configured to extend in a direction that is at least substantially perpendicular to the cannula axis and lysing tip1310 (the axis between the twoouter beads1351a/1351d) may be configured to extend in a direction that is at least substantially parallel to the cannula axis. In addition, in the depicted embodiment, lysingtip1310 may be configured such that an energy delivery side of lysingtip1310 in front ofprotrusions1301 defined by the leading/proximal tips ofbeads1351 and therelative recessions1302, which energy delivery side will ultimately deliver electrosurgical energy for dissecting tissue, faces an interior surface of a lumen ofcannula1331 through whichlysing tip1310 is delivered. Following delivery of lysingtip1310 through a distal end ofcannula1331,system1300 may be configured to reposition lysingtip1310 to the treatment configuration in which the energy delivery side extends at least substantially perpendicular to the cannula axis.
As shown inFIG.13d,system1300 comprises two separate cannulas, namely, a first or first/inner/device cannula1331 which preferably comprises a lumen of sufficient diameter to allow folded lysing tip1310 (in a delivery configuration) to be positioned within the lumen of first/inner/device cannula1331, and asecond cannula1332, which may have a larger cross-sectional diameter. In some embodiments and implementations, lysingtip1310 may be configured such that itsbeads1351 are too large to fit within the lumen of first/inner/device cannula1331, even in the delivery configuration. Thus, lysingtip1310 in its delivery configuration may be positioned just outside (immediately distal) of first/inner/device cannula1331 but within second/outer cannula1332 during delivery. By providing two co-axial cannulas,actuation rods1321 and1322 and/or actuation rod pairs1321/1323 and1322/1324 may be prevented, or at least substantially prevented, from being separated from one another or otherwisesystem1300 may be configured to maintain better control over lysingtip1310 during deployment. Thus, preferably,actuation rods1321/1322 and/or actuation rod pairs1321/1323 and1322/1324 are also delivered through first/inner/device cannula1331.Retraction1325 is preferably neartip1310 at or near the distal end of one ofactuation rods1321/1322.
In this embodiment,distal actuation rods1321 and1322 are formed with two bends that bring the distal end of the actuation rods perpendicular with the main axis of the actuation rods but parallel to the elongated axis of thelysing plate1360 in the treatment configuration. This configuration may be advantageous during the delivery configuration to optimize the volume needs within cannulas. In the present embodiment,actuation rods1321 and1322 may have cutouts in the distal tips allowing for lysingplate1360 to be received in the distal tips ofactuation rods1321/1322. Alternatively, the lysingplate1360 may comprise recesses that permit theactuation rods1321/1322 to seat within the lysingplate1360.
Lysing tip1310 may comprise an orientational-deployment side opposite from the energy delivery side. The orientational-deployment side of lysingtip1310 may be configured to allow lysingtip1310 to be repositioned between the delivery configuration and the treatment configuration described above. A deployment assembly may be coupled with the orientational-deployment side of lysingtip1310. This deployment assembly may be configured to allow for selective repositioning between the delivery and treatment configurations. In the depicted embodiment, the deployment assembly may comprise one or more pivot members, such aspivot members1316 and1317.Pivot members1316 and/or1317 may comprise various elements configured to allow for selective pivoting, rotation, and/or angulation of lysingtip1310, such as joints, ball pivots, hinges, pins, groove/slot pairs, etc., such that lysingtip1310 can be pivoted, rotated, or “folded” between its deployment and treatment configurations.
Pivot members1316 and1317, such as pins or the like, may be coupled at one end to thelysing plate1360 atholes1368aand1368band may be further coupled withactuation rods1322 and1321, respectively. In some embodiments,pivot members1316/1317 may therefore be configured to be received in holes formed in both lysingplate1360 and corresponding aligned holes formed withinactuations rods1321/1322. Thus, upon advancing one or both ofactuation rods1322 and1323, lysingtip1310 may be advanced in its delivery configuration down first/inner/device cannula1331. In some embodiments, appropriate wires or other transmission lines for delivery of electrosurgical energy may be positioned to extend through one or more of the various actuation rods. Alternatively, in some embodiments, electrosurgical energy may be delivered directly through one or more actuation rods. In some embodiments, wires or other transmission lines for delivery of electrosurgical energy may instead, or additionally, extend though other regions of lumen, as previously described.Actuation rods1321 and/or1322 and/or actuation rod pairs1321/1323 or1322/1324 may comprise any suitable material depending on whether electrosurgical energy is being delivered through them. For example, a metal or other conductive material may be used if electrosurgical energy is to be delivered through the actuation rods, or a plastic or other insulating material may be used if electrosurgical energy is to be delivered through separate wiring or other suitable transmission lines.
Some embodiments may further comprise one or more additional joints and/or pivot members positioned proximally relative to pivotmembers1316 and1317. For example, some such embodiments may comprise hinges and/orpivot members1327/1328 that are positioned within one or both of actuation rod pairs1321/1323 or1322/1324, as previously described inFIGS.1a-j. Such hinges may allow for one or both ofdistal actuation rods1321/1322 to be pivoted/rotated in a desired direction once lysingtip1310 has exited the terminal end ofcannula1331 and/or1332.
System1300 differs fromSystems800 and900 in that lysingmember1360 comprises aplate1360.Plate1360 may extend throughhorizontal tunnels1352 within thevarious beads1351.Beads1351 may also havevertical tunnels1355. Thus,beads1351 may be more permanently coupled withplate1360 by way of holes withinplate1360, such as1369a/1369b/1369c/1369dformed withinplate1360 configured to correspond toholes1355 located inbeads1351. In some embodiments, pins, screws, rivets or the like or epoxy, or metallic welds may extend throughvertical tunnels1355 andholes1369a/1369b/1369c/1369dto affix the two elements together. In alternative embodiments,holes1369a/1369b/1369c/1369dmay be replaced by bevels. Thus, in some embodiments, horizontal and/or vertical tunnels may not be needed. However, in other embodiments,plate1360 may comprise beveled or narrowed regions configured to fit within such tunnels formed withinbeads1351. Because use of aplate1360 may provide more rigidity than certain other embodiments, use of spacers may not be needed for lysingtip1300.
System1300 comprises areas between each of the adjacent protrusions1301 (defined by the distal/front ends ofadjacent beads1351a-d) that definerecessions1302.Plate1360 may define lysingsegments1360a/1360b/1360cthat are positioned between each of theadjacent beads1351a-d. Each of these lysing segments may be collectively defined by a single lysing member/plate1360 or, in other embodiments, separate lysing members/plates may be used for each of the lysing segments positioned between adjacent protrusions/beads.
As shown inFIG.13d, the hinge structure may allow for rotation of lysingtip1310 above and/or below the cross-sectional profile ofcannula1331 and/or1332 and may allow lysingtip1310 to extend beyond the cross-sectional profile ofcannula1331 and/or1332 along one or both of the opposing ends of thelysing tip1310.
It should be understood that embodiments are contemplated wherein the dimensions of the tip relative to acannula1331 may vary as for example, as shown inFIGS.16kand16L. In other words, thelysing tip1310 in the axial deployment configuration may be unable to be received withincannula1331 such as shown inFIG.16L or may be unable to be received within an inner cannula of two delivery cannulas as shown inFIG.16k. In embodiments comprising two cannulas, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip can correspond to the larger diameter outer cannula as opposed to being limited to the smaller dimensions of the inner/device cannula. In embodiments comprising a single cannula, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip in its axial/delivery configuration only need to correspond to the size of the entrance incision. With respect to such embodiments, the single cannula may primarily serve to protect and stabilize the control rods and provide rigidity to the assembly. Such embodiments may be useful for cosmetic procedures within the skin, for example, but not limited to, for face lifting and/or cellulite treatment.
Another embodiment is depicted inFIGS.14a-14n.System1400 comprises lysingtip1410 comprisingrecessions1402 created byadjacent protrusions1401.Lysing tip1410 further comprises asupport member1470 defining a bow shape through which holes1472 and1473 extend vertically. In the depicted embodiment,hole1472 is offset fromhole1473 onsupport member1470, such as with respect to the lysingrod1460, for example. This may facilitate a preferred pivoting of lysingtip1410 between treatment and delivery configurations.Holes1472/1473 may configured to receive pins forcoupling lysing tip1410 toactuation rods1422 and1421 respectively.Support member1470 and/orholes1472/1473, in some embodiments, may not be symmetrical with respect to one or more points and/or axes, such as one or more central axes of lysingtip1410, such as the axis defined by lysingrod1460 and/or the center axis of thelysing tip1410 from a plan view extending between the treatment and deployment/orientation sides of thelysing tip1410, in order to facilitate movement between the treatment and delivery configurations. For example, in the depicted embodiment, if an XY grid is imposed overFIG.14gwith the Y-axisbifurcating lysing rod1460 and the X-axis touches the lower most feature ofsupport member1470, then holes1472 and1473 may not have the same y-coordinate. In other words,holes1472 and1473 may be positioned at different distances from lysingrod1460 or are non-symmetrical with respect to lysingrod1460. Furthermore, in some embodiments,holes1472/1473 may be positioned at different distances from the center ofsupport member1470.
Support member1470 may be preferably insulated, except within one or both sets of its two sets of holes, to prevent unwanted delivery of electrosurgical energy to tissues; thus, electrosurgical energy is directed to support member holes at whichlysing rod1460 becomes energized for energy delivery.
In the depicted embodiment, knobs1475aand1475bare provided onsupport member1470 in order to provide additional material support such that holes1472 and1473 can be formed in a desired location. In this embodiment, holes1472 and1473 may be positioned within and/or adjacent toknobs1475aand1475brespectively.
Lysing tip receptacle1421aondistal actuation rod1421 comprises a cutout formed in the distal control arm into which the bottom ofsupport member1470 recesses. In other embodiments, the lysing tip receptacle may instead comprise a recess that is not fully cut out.
Actuation rod1422 further comprises opening1422asuch that when lysingtip1410 is in the delivery configuration, fastening member ofhinge1427 enters opening1422ato facilitate maximum proximal movement of the actuation rods relative to each other.
As shown inFIG.14c,system1400 comprises two separate cannulas, namely, anouter cannula1432 which preferably comprises a lumen of sufficient diameter to allow folded lysing tip1410 (in a delivery configuration) to be positioned within the lumen ofcannula1432, and a first inner/device cannula1431 which comprises a lumen of sufficient diameter to allow folded lysing tip1410 (in a delivery configuration) to be positioned within the lumen ofcannula1431. In certain embodiments, such as inFIGS.14iand14j, lysingtip1410 in the delivery configuration may have one or more cross-sectional dimensions that may exceed the inner diameter of inner/device cannula1431 and thus may not retract partially or fully into inner/device cannula1431. However, in some such embodiments, lysingtip1410 may still retract fully intoouter cannula1432 during deployment or retraction. More particularly, lysingtip1410 may be configured such that itsbeads1451a/b/c/dare too large to fit within the lumen of inner/device cannula1431, even in the delivery configuration. Thus, lysingtip1410 in its delivery configuration may be positioned just outside (immediately distal) of inner/device cannula1431 but withinouter cannula1432 during delivery.
Any of the embodiments described herein may be configured such that thetip1410 cannot be fully received withinsecond cannula1432 as shown inFIG.14c. Or alternatively, any of the embodiments disclosed herein such that the entire tip may be fully received within first/inner/device cannula1431. This embodiment may be useful because it permits the tip to be as large as possible given the dimension constraints of the outer cannula and not the inner cannula thus reducing the expense of further miniaturizing.
Some embodiments may be configured such that lysingtip1410 is not aligned with the axis ofcannulas1431 or1432 in the delivery configuration. More particularly the axis of lysingtip1410 may be positioned at an acute angle with respect to the axis ofcannulas1431 or1432. In other embodiments, lysingtip1410 may be configured to extend at an acute angle relative to the cannula axis so long as the axis of lysingtip1410 fits within the lumen and/or lumens of one and/or both cannulas such as illustrated inFIG.10for11f
By providing two co-axial cannulas,actuation rods1421 and1422 may be prevented, or at least substantially prevented, from being separated from one another or otherwisesystem1400 may be configured to maintain better control over lysingtip1410 during deployment. Thus, preferably,actuation rods1421 and1422 are delivered through bothcannulas1431 and1432.
Lysing rod1460 extends through all beads and terminates inouter beads1451a/1451dcoupling all beads with lysingrod1460 andstructural member1470 viacoupling tips1463 terminating withinouter beads1451a/1451d. In this embodiment, the configuration of the tunnels in the middle and end beads may capture corresponding elements as described in previous embodiments. In some embodiments, it may be desirable to provide features and/or elements that inhibit or limit the ability of the electrosurgical energy to discharge from the opposing ends of the lysingrod1460 atcoupling tips1463/1464. Thus, in some such embodiments,coupling tips1463/1464 may be coated or covered with a suitable insulating material such as an epoxy with non-conductive properties. Alternatively,outer bead hole1454 at the end with the larger-opening may be capped or plugged with an element configured to be received or otherwise engage the larger opening of the bead. Preferably, this element will have non-conductive properties similar to the insulating material previously referenced.
In this embodiment,spacers1462a/1462b/1462cmay be positioned betweenbead pairs1451a/1451b,1451b/1451c, and1451c/1451d. In the depicted embodiment, each of the respective lysing segments between each bead pair comprises a spacer1462 (1462a/1462b/1462c) that may be configured to space thevarious beads1451a/b/c/dapart, provide stability to the lysing tip, and/or protect the respective lysing segments (which, in the depicted embodiment, are collectively defined by a single lysing member/lysing rod1460). Preferably,spacers1462 comprise a conductive material, such as a suitable biocompatible metal, that can receive electrosurgical energy from the lysingmember1460 and deliver it to various internal body tissues during a surgical procedure. Preferably, spacer(s)1462 are therefore in direct contact with lysingmember1460. In some embodiments, asingle spacer1462 may both extend between thevarious beads1451a/b/c/dand extend through thetunnels1454 through thebeads1451a/b/c/d. In some contemplated embodiments, spacers may be comprised of insulating materials (such as ceramic, glass, plastic and the like) that may have holes and/or be porous and/or have breaks and/or have separations such that energy from lysing member(s) within may be released into target tissues to have effect such as that illustrated inFIG.12j. As discussed earlier, in some embodiments, spacers may have a circular cross-sectional profile which may facilitate adhesion of surface coatings which may have functions, including but not limited to, such as reduction in char buildup and/or ease of movement of lysing tip through tissue. However, in some embodiments electrical discharge may be enhanced across the length of the lysingmember1460 via a cross sectional profile with acute or substantially acute angles, for example, pentagonal or hexagonal shapes. Additionally, spacers with non-circular cross-sections may accumulate less debris and/or eschar on lysing rod and/or spacer because debris may have a more difficult time adhering to an angled edge.
Beads1451a-dmay be positioned along lysingrod1460 differently in alternative embodiments. For example, inFIG.14h, in some embodiments,spacers1462a-cmay be removed and protuberances1465c/1465dsuch as welds may be placed on each side of themiddle beads1451b/cand may face proximally, distally or therebetween. In alternative embodiments,spacers1462a-cmay be removed and lysingrod1460 may be deformed on each side of themiddle beads1451b/csuch that the beads may not slide past the deformation. With respect to such embodiments, these deformations may also be considered protuberances as this term is used herein. In alternative embodiments,spacers1462a-cmay be removed and lysingrod1460 may be deformed, such as flattening, making ellipsoidal in cross section, or otherwise modified, prior to coupling with the middle bead(s) such that the outer diameter of lysingrod1460 may couple via friction fit with the inner tunnel surface ofmiddle beads1451b/c. In alternative embodiments,spacers1462a-cmay be deformed on lysingrod1460 to a degree that spacers may no longer rotate around lysingrod1460 and the new cross-sectional shape ofspacers1462a-cmay have a beneficial effect.
In the current embodiment,outer beads1451aand1451dare the approximate same length asmiddle beads1451band1451c; this shorter outer bead configuration may allow for more complete folding of the lysing tip during the delivery configuration.
Retraction guide1425 is preferably neartip1410 at or near the distal end of one ofactuation rods1421/1422. In the depicted embodiment,retraction guide1425 is positioned near the distal end ofactuation rod1422 adjacent to (immediately proximal of)tip1410. In some embodiments,retraction guide1425 may comprise a resilient material, such as a spring, so that it provides a restorative force during retraction oftip1410 intocannula1431. Preferably,retraction guide1425 is positioned and configured so as to extend fromactuation rod1422 laterally by a distance at least approximately equal to, in some embodiments slightly greater than, the distance one or more of theprotrusions1401 that extend laterally relative toactuation rod1422 in the retracted/folded configuration. In some embodiments,retraction guide1425 may extend in this direction a distance equal to, or slightly greater than, the largest protrusion1401 (in embodiments in which each of the protrusions are not identical and/or do not project an equal distance).
It should be understood that embodiments are contemplated wherein the dimensions of the tip relative to acannula1431 may vary as for example, as shown inFIGS.14kand14L. In other words, thelysing tip1410 in the axial deployment configuration may be unable to be received withincannula1431 such as shown inFIG.14L or may be unable to be received within an inner cannula of two delivery cannulas as shown inFIG.14k. In embodiments comprising two cannulas, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip can correspond to the larger diameter outer cannula as opposed to being limited to the smaller dimensions of the inner/device cannula. In embodiments comprising a single cannula, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip in its axial/delivery configuration only need to correspond to the size of the entrance incision. With respect to such embodiments, the single cannula may primarily serve to protect and stabilize the control rods and provide rigidity to the assembly. Such embodiments may be useful for cosmetic procedures within the skin, for example, but not limited to, for face lifting and/or cellulite treatment.
Some embodiments could be configured to allow for treatment to take place from the tip at a non-perpendicular angle relative to the axis of the cannula. In some such embodiments, this non-perpendicular angle may even allow the tip to be withdrawn in this treatment configuration. Thus, such embodiments may be configured such that some deployment configurations may also be considered treatment configurations. In alternative embodiments, the lysing tip may be reconfigured to rotate 180 degrees allowing for angling of the tip in either direction relative to the normal of the axis of the cannula. Thus, in this manner a lysing tip could be used to treat in a first lateral direction and also a second lateral direction opposite to the first lateral direction such as inFIGS.14b,14k, and/or14/L.
In the current embodiment, hinges1427/1428 couple actuation rod pairs1421/1423 and1422/1424 allowing a pivoting movement in both vertical directions.
Some embodiments may utilize aprotective sleeve1499 whichsleeve1499 may serve to protect the tip (either a lysing tip or tissue modification tip (TMT)) during deployment such as those depicted inFIGS.14k-n. In some embodiments theprotective sleeve1499 may comprise a biodegradable material such as gelatin. Preferably theprotective sleeve1499 is positioned about the distal end of the tip during deployment. In embodiments in which theprotective sleeve1499 is biodegradable, thesleeve1499 may begin to degrade once deployed in the body. Alternatively, theprotective sleeve1499 may not be biodegradable in which case the sleeve may be withdrawn from the tip by another instrument. In some embodiments, thesleeve1499 may be withdrawn by positioning the sleeve covered tip within the body and then withdrawing the tip to remove the sleeve. In other embodiments, thelysing tip1410 may be configured to rotate up to 180 degrees to a point to allow the sleeve to be withdrawn. In alternative embodiments,sleeve1499 may comprise a weakenedseam1499′ such that when lysingtip1410 is rotated, the weakenedseam1499′breaks allowing sleeve1499 to disengage lysingtip1410. For example, weakenedseam1499′ may comprise a series of cuts or scorings. In some embodiments, thesleeve1499 may be made up of a material configured to utilize body fluids to provide a slippery or non-frictional surface.
In the depicted embodiment,1447 represents an antenna configured to deliver a signal to a receiver unit.Antennae1447 may be located withinhole1455. In some embodiments,antenna1447 may comprise radiofrequency identification (RFID) TAG. In some embodiments the RFID tag may comprise an RFID transponder. In other embodiments the RFID tag may comprise a passive tag. It should be understood thatantenna1447 is not depicted in every one of the other figures; any of the embodiments described herein may comprise one or more such elements. Other embodiments may comprise one or more antenna on any other suitable location on the embodiment, including but not limited to on the protrusions or otherwise on the tip, and on the shaft. In embodiments in whichantenna1447 comprises an RFID transponder, the RFID transponder may comprise a microchip, such as a microchip having a rewritable memory. In some embodiments, the tag may measure less than a few millimeters. In some embodiments a reader may generate an alternating electromagnetic field which activates the RFID transponder and data may be sent via frequency modulation. In an embodiment, the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range. The position may be related to a 3 dimensional mapping of the subject. In an embodiment the reader may generate an alternating electromagnetic field. In some such embodiments, the alternating electromagnetic field may be in the shortwave (13.56 MHz) or UHF (865-869 MHz) frequency. Examples of potentially useful systems and methods for mapping/tracking a surgical instrument in relation to a patient's body may be found in U.S. Patent Application Publication No. 2007/0225550 titled “System and Method for 3-D Tracking of Surgical Instrument in Relation to Patient Body”, which is hereby incorporated by reference in its entirety.
In some embodiments, a transmission unit may be provided that may generate a high-frequency electromagnetic field configured to be received by an antenna of the RFID tag or another antenna. The antenna may be configured to create an inductive current from the electromagnetic field. This current may activate a circuit of the tag, which may result in transmission of electromagnetic radiation from the tag. In some embodiments, this may be accomplished by modulation of the field created by the transmission unit. The frequency of the electromagnetic radiation emitted by the tag may be distinct from the radiation emitted from the transmission unit. In this manner, it may be possible to identify and distinguish the two signals. In some embodiments, the frequency of the signal from the tag may lie within a range of the frequency of the radiation emitted from the transmission unit. Additional details regarding RFID technology that may be useful in connection with one or more embodiments discussed herein may be found in, for example, U.S. Patent Application Publication No. 2009/0281419 titled “System for Determining the Position of a Medical Instrument,” the entire contents of which are incorporated herein by specific reference.
In other embodiments,antenna1447 may comprise a Bluetooth antenna. In such embodiments, multiple corresponding Bluetooth receivers at known locations may be configured to sense signal strengths from theBluetooth antenna1447 and triangulate such data in order to localize the signal from theBluetooth antenna1447 and thereby locate the lysing tip within a patient's body. Other embodiments may be configured to use angle-based, electronic localization techniques and equipment in order to locate theantenna1447. Some such embodiments may comprise use of directional antennas, which may be useful to increase the accuracy of the localization. Still other embodiments may comprise use of other types of hardware and/or signals that may be useful for localization, such as WIFI and cellular signals, for example.
One or more receiver units may be set up to receive the signal from the tag. By evaluating, for example, the strength of the signal at various receiver units, the distances from the various receiver units may be determined. By so determining such distances, a precise location of the lysing tip relative to a patient and/or a particular organ or other surgical site on the patient may be determined. In some embodiments, a display screen with appropriate software may be coupled with the RFID or other localization technology to allow a surgeon to visualize at least an approximate location of the tag/antenna, and therefore the lysing tip, relative to the patient's body.
Some embodiments may be further configured such that data from the antenna(s) may be used in connection with sensor data from the device. For example, some embodiments comprising one ormore sensors1448 may be further coupled with one or more RFID tags. One ormore sensors1448 may be located within one ormore holes1455. As such, data from the one or more sensors may be paired or otherwise used in connection with data from the one or more RFID tags or other antennas. For example, some embodiments may be configured to provide information to a surgeon regarding one or more locations on the body from which one or more sensor readings were obtained. In some embodiments, temperature sensors may include thermistors and/or thermocouples. To further illustrate using another example, information regarding tissue temperature may be combined with a location from which such tissue temperature(s) were taken. In this manner, a surgeon may be provided with specific information regarding which locations within a patient's body have already been treated in an effective manner and thus which locations need not receive further treatment using the device.
In some such embodiments, a visual display may be provided comprising an image of the patient's body and/or one or more selected regions of a patient's body. Such a system may be configured so as to provide a visual indication for one or more regions within the image corresponding to regions of the patient's tissue that have been sufficiently treated. For example, a display of a patient's liver may change colors at locations on the display that correspond with regions of the liver that have experienced a sufficient degree of fibrosis or other treatment. Such regions may, in some embodiments, be configured such that pixels corresponding to particular regions only light up after the corresponding tissue in that region reaches a particular threshold temperature.
Such sensor1448 may be coupled with an antenna, which may send and/or receive one or more signals to/from a processing unit. Alternatively, or additionally, data from such sensors resulting from tissue and/or fluid analysis using such sensors may be stored locally and transmitted later. As yet another alternative, such a signal may be transmitted following surgery. In such implementations, the signals need not necessarily be transmitted wirelessly. In fact, some embodiments may be configured to store data locally, after which a data module, such as a memory stick, may be removed from the device and uploaded to a separate computer for analysis.
In alternative embodiments which may be helpful for skin/cosmetic procedures, the TD tip and/or the anticipated and/or previous paths may be visualized using for example an internal camera such as an endoscopic or laparoscopic camera, and/or an external camera such as an infrared camera, (for example, a FLIR camera), an RFID tag or other antenna. In some implementations, such a device or devices may be positioned on the TD. In other implementations such a device or devices may be separate from the TD. A real time display may be created using the data of the cameras and/or antennae and/or tags, for example, showing the exact location of the tip and the during- and post-passage temperature effects. In alternative embodiments, the software presenting the visual information may hold (or slow the decay back to the body temperature) the color (designating temperature) at its maximum value during the remainder of the procedure so that the surgeon will know where the TD tip has been.
In some embodiments,system1400 may comprise canal(s)1404 (only depicted inFIG.14d) which may be positioned to supply one or more fluids to the surgical site around or near lysingtip1410 via a port located adjacent to the internal device cannula and/or lysing tip.Canal1404 may be configured to be extended and withdrawn as needed. In alternative embodiments, other fluids that may pass downcanal1404 may include, but not be limited to, cold nitrogen gas, fluorocarbons, etc., which might cool and/or freeze tissue to alter it in a desired fashion.
FIGS.14o-14tdepict an example of amodular lysing tip1410′ comprising atreatment portion1411′ of lysing tip and areusable base portion1470L.Treatment portion1411′, which may be disposable in some embodiments, is reversibly coupled withbase portion1470L. Thus, upon completing an electrosurgical procedure, the user may removetreatment portion1411′, and its accompanyinglysing rod1460 andbeads1451, frombase portion1470L and reattach a new treatment portion for a subsequent surgery.
In the depicted embodiment,treatment portion1411′ may be coupled withbase portion1470L aligning aseat1470u′ formed inupper support member1470uoftreatment portion1411′ with a locking portion comprising a pair of opposingflanges1470feach of which comprises ahooked end portion1470h.Seat1470u′ in some embodiments may comprise a narrowed region ofupper support member1470u. Thus, upon insertingseat1470u′ between opposingflanges1470f, hookedend portions1470hengage an upper surface ofupper support member1470uin the region ofseat1470u′ as depicted inFIG.14t. As best illustrated inFIG.14r,base portion1470L may comprise a lower support member configured to mate withupper support member1470usuch that together they define a full support member as previously described. In addition, because theupper support member1470uoftreatment portion1411′ will likely be used only once or otherwise less thanbase portion1470L, preferably, holes1472 and1473 are formed inbase portion1470L. As previously describedholes1472 and1473 may be used to facilitate coupling of lysingtip1410′ with a deployment assembly as depicted inFIG.14o.
After performing an electrosurgical procedure usinglysing tip1410′,upper support member1470umay be removed frombase portion1470L by, for example, pullingseat1470u′ out of the locking portion ofbase portion1470L. In some cases, a user may pull or pry opposingflanges1470fapart either by hand or by use of a suitable tool during this decoupling process.FIGS.14p,14s, and14tare cross sectional views taken at line A-A depicted inFIG.14r.
FIGS.15a-15kdepict an alternative embodiment of aCDTD system1500 comprisingbeads1551a/b/c/dcoupled with a bow/support member1570 and further comprising an energy window made up of a plurality ofelectrode termini1506a/1506b/1506c/1506dfor delivering energy such as RF. Bow/support member1570 may be coupled toactuation arms1521 and1522 and delivered throughcannulas1531 and1532 may be employed. In some embodiments the RF energy delivered by thetermini1506a/1506b/1506c/1506dmay be distinct from the RF energy delivered by the lysing segments between the adjacent beads. Beads may comprisefacets1552 andtunnels1554. More particularly, in the depicted embodiment, the energy window comprises anenergy window strip1507 which is preferably made of a conductive material.Energy window strip1507 comprises a plurality ofenergy window termini1506a/1506b/1506c/1506dprotruding from theenergy window strip1507. Aninsulation cover1508 may be configured to be coupled withenergy window strip1507. In someembodiments insulation cover1508 may be molded ontoenergy window strip1507. Alternatively theinsulation cover1508 may be configured to receive theenergy window strip1507 or otherwise be coupled withenergy window strip1507. Preferably, theinsulation cover1508 comprises a non-conductive material. In the depicted embodiments, theinsulation cover1508 comprises an elongated base configured to cover the energy window strip but allow theenergy window termini1506a/1506b/1506c/1506dto protrude through theinsulation cover1508. In addition, theinsulation cover1508 comprises a plurality of protrudingbead coupling members1508′, each of which is configured to extend into and be coupled with one of the beads of the tip via hole1555 (as shown inFIG.15i, a cross-sectional view down/through the center ofouter bead1551d).Energy delivery conduit1509 such as a wire may be coupled with theenergy window strip1507. Preferably, theenergy delivery conduit1509 is insulated from the energy delivery conduit that delivers energy to the lysingsegments1561a/1561b/1561csuch that a distinct type of energy may be delivered therethrough.
In other embodiments, energy window may be configured to utilize energy of different modalities, including, but not limited to, laser, intense pulse light, resistive heating, radiant heat, thermochromic, ultrasound, mechanical, and/or microwave.
In some embodiments,system1500 may be configured to utilize bipolar radiofrequency energy as depicted inFIGS.15j(energy conduits not shown) and15k. In the depicted embodiment, each electrode termini may be physically independent of the other, however, electrode termini pairs1506a′/1506c′ and1506b′/1506d′ may each be electrically coupled to apositive energy conduit1509nand anegative energy conduit1509p, respectively. In some embodiments, the energy conduits may comprise wires.
FIGS.16a-16hdepict an alternative embodiment of aCDTD system1600 comprising a plurality ofprotrusions1601 andrecessions1602 positioned in between adjacent protrusions.System1600 is structurally similar tosystem1400, however,system1600 is a bipolar device.System1600 further comprises first/inner/device cannula1631 and second/outer cannula1632, the first or both which may be used to deliver lysingtip1610, as previously mentioned.System1600 is configured for bipolar electrosurgical energy delivery, has 3 protrusions defined by beadsouter beads1651a/1651bandmiddle bead1652, and 2 lysing segments1668ps/1668nsdefined by two electrically isolated lysing members1668pm/1668nm.
In the embodiment ofFIG.16f, negative lysing member1668nmis configured to extend through atunnel1658nformed inbead1652. Similarly, positive lysing member1668pmis configured to extend through aseparate tunnel1658pformed in1652. Positive lysing member1668pmand negative lysing member1668nmmay extend from their respective tunnels all the way back to an electrosurgical generator and/or surgical instrument. In other embodiments lysing members1668pm/1668nmmay instead terminate withinbead1652 or may terminate somewhere in betweenbead1652 and its ultimate electrical coupling with an electrosurgical energy source. For example, in some embodiments, a wire or another electrical conductor may be coupled to lysing members1668pm/1668nm.
In some such embodiments, the lysing tip comprises means for maintaining a flexible lysing member in a rigid state. Examples of such means may include a weld, melt, crimp, bend, narrowing of tunnel, and the like. In a more particular example of such a means,protuberance1668bmay be formed adjacent to one or more of the openings oftunnel1658por1658nsuch that lysing members1668pm/1668nmmay be pulled through their respective tunnels and tightened or kept taught after which protuberances1668bmay be formed to keep their respective lysing members in a rigid or substantially rigid state. In another embodiment,bead1652 may be formed in two pieces and coupled together after positioning lysing members1668nm/1668pmthrough their respective tunnels. In some such embodiments, the tunnels may be formed at least in part with a diameter equal to or less than that of lysing member1668nm/1668pmsuch that upon applying both pieces together the lysing members may be prevented from being withdrawn from their respective tunnels.
InFIG.16e, the wiring comprising lysing member1668p/1668nhas been removed in order to show theactuation rods1621/1622 from the cannula distally to thelysing tip1610.Lysing tip1610, more particularlystructural member1670, in the delivery configuration, seats insidegroove1621a.
An external power cord may bring electrosurgical energy from an electrosurgical generator to a hand assembly, such as that illustrated inFIG.1,system1600, (which is electrically connected) to lysing member1668pm/1668nm(which may be insulated through cannula lumen) directly to lysingtip1610. In this embodiment, each lysing member1668pm/1668nmenters itsrespective tunnel1658p/1658nthrough the rear ofcenter bead1652, and exits an opposite side ofbead1652 wherein lysing member1668pm/1668nm, preferably no longer be insulated after exiting1652, defines lysing segments1668ps/1668nswhereupon each enters its respectiveouter bead1651a/1651band terminates withinbeads1651aor1651bas previously described herein viacoupling tips1663.
The tip shown in this embodiment has threerelative protrusions1601, lysing members1668pm/1668nm(and associated lysing segments1668ps/1668ns), withbeads1651a/1651b/1652 pointing along the main axis of the CDTD in treatment configuration. In other embodiments, the bipolarCDTD lysing tip1610 may have one or more non-axial protrusions and one or more non-axial relative recessions. In some embodiments, the tip may have between 3 and 100 axial and/or non-axial protrusions and/or relative recessions. It should be understood that the number of protrusions need not match the number of lysing elements or recessions. In some embodiments, lysing elements may be located at the termini of conductive elements. In some embodiments, lysing elements may also be made partially or completely of a cermet material. In an embodiment, the modularbipolar CDTD tip1610 may measure about 15 mm in length (TL inFIG.10e) and/or about 3 mm in height (TH inFIG.10d). Embodiments are contemplated wherein sizes of about one-fifth to about five times these dimensions may have possible uses. It is also contemplated, for example in some veterinary embodiments, tip sizes of about one-tenth to 20 times the aforementioned dimensions may have possible uses. In other contemplated embodiments, electroconductive leads may course from an electrosurgical generator via first/inner/device cannula1631 to energize various lysing elements located inbipolar CDTD tip1610. In some embodiments leads may comprise wires and/or conductive conduits.
FIG.16gis an anterior elevated perspective view of lysingtip1610. In this embodiment, individual lysing segments1668ps/1668nsmay comprise surgical grade conductive metals and/or alloys positioned within all and/or a portion of one or more pieces of ceramic and/or other thermally resistant, non-conductive housing. In some embodiments, one or more individual lysing elements/segments may comprise electroconductive materials including but not limited to cermets, steel, nickel, alloys, palladium, gold, tungsten, titanium, silver, copper, and/or platinum. In the depicted embodiment, the lysing elements may measure about 2 mm in length, and about 0.5 mm in diameter/thickness.
In this embodiment, the configuration of the tunnels in the end beads may capture corresponding elements as described in previous embodiments. For example, certain beads may comprisehole1655 that may be positioned perpendicular to lysingrod hole1658;holes1655 may be available as a platform/location to add other features/components such as providing a location for coupling of a cord as described below in connection with other embodiments and/or locating a sensor and/or RFID location component and/or being used for placement of luminescent and/or light production element(s) for visualization, for example, tritium and the like.
In some contemplated embodiments there need not be equal numbers of oppositely signed and/or charged individual lysing elements. Uniformity of flux on activation may be achieved by modifying the size and/or position of lysing elements with respect to each other among other methods known in the art.
The relative static permittivity of some ceramics may range from about 5 to 10; this may cause some leakage of current in an undesirable path between closely approximated opposing electrodes during activation. Use of other materials, for example, those having over of relative static permittivities of 5 may undesirably alter the resultant plasma field. The relative static permittivity of the intervening materials housing the opposing electrodes may be enhanced by coating and/or surrounding and/or injection molding thermoresistant polymers of a low relative static permittivity into the housing and/or around one or more portions of bipolar lysing segments1668ns/1668psto reduce the effective static permittivity of the tip. In an embodiment, the thermoresistant polymer of low relative static permittivity 2.1 may be polytetrafluoroethylene. In other contemplated embodiments, thermoresistant polymers may include polyether etherketone (@3.3) and/or polysulfone (@3.1) and the like may be useful.
In the depicted embodiments, the electrical insulator on lysing member1668nm/1668pmand/orsupport member1670 may comprise polytetrafluoroethylene. In other contemplated embodiments, the electrical insulator may comprise an electrically nonconductive polymer with a high melting temperature. In some embodiments, the nonconductive polymer may comprise for example, polyether etherketone and/or polysulfone, etc. In other contemplated embodiments, the electrical insulator may comprise an electrically nonconductive and/or thermally nonconductive polymer.
In some embodiments and implementations, lysingtip1610 may be configured such that itsbeads1651a/band1652 are too large to fit within the lumen of first/inner/device cannula1631, even in the delivery configuration. Thus, lysingtip1610 in its delivery configuration may be positioned just outside (immediately distal) of first/inner/device cannula1631 but within second/outer cannula1632 during delivery.
FIGS.17a-17mdepict yet another embodiment of a CDTD or anon-CDTD system1700.System1700 comprises alysing tip1710 that is configured to be completely separable from any other element of the system. In this manner as depicted inFIGS.17f-g, lysingtip1710 may be delivered through a first/primary cannula1732, which may comprise, for example, a trocar, and then coupled with a first surgical tool, such as a grasping/control instrument1790 that can be used to control and/or energize thelysing tip1710 within the body of a patient during a surgical procedure. In some embodiments and implementations, a second cannula may be used to deliver a second surgical tool, such as a transfer/graspinginstrument1796, that may be used to facilitate coupling of lysingtip1710 to the grasping/control instrument1790, which instrument may be delivered through thesame cannula1732 through which thelysing tip1710 is delivered. In some embodiments, grasping/control instrument1790 may have the same configuration as grasping/transfer instrument1796. In alternative embodiments, transfer/graspinginstrument1796 may be configured differently from graspingcontrol instrument1790 in that, for example, it may not have the capability to transfer energy to lysingtip1710 yet may have a different tip design in order to facilitate grasping/holdinglysing tip1710 between two beads or other protrusions. Alternatively, thelysing tip1710 may be delivered though a secondunattached cannula1735 along with a grasping/transfer instrument1796 used to couple thelysing tip1710 to the first surgical tool delivered through the first/primary cannula, which other surgical tool may be used to control lysingtip1710 and perform the surgical procedure. As shown in theFIG.17f, lysingtip1710 is positioned withinouter cannula1732 with an axis extending between theoutermost beads1751a/1751din lysingtip1710 aligned with a primary axis ofcannula1732 and with a treatment side of lysing tip1710 (opposite from grasping pad1771) facing an internal surface ofcannula1732.
In some implementations ofmethods using system1700, the lysing tip may be reconfigured from a delivery configuration to a treatment configuration by deliveringlysing tip1710 through a cannula at least substantially along a treatment axis of the lysing tip extending between opposing outer beads and then rotating the lysing tip once outside the distal end of the cannula. In some such implementations the step of reconfiguration the lysing tip from delivery to treatment configuration may further comprise grasping a portion of the lysing tip such as the grasping pad in a manner such that the treatment axis is at least substantially perpendicular to an axis of the grasping instrument. Thus, the lysing tip may be grasped from a direction at least substantially perpendicular to the grasping direction in the treatment configuration during delivery.
In alternative implementations, a standard 3-5 mm diameter grasping instrument with handle (without a lysing tip attached) may be directed into the body cavity, possibly via a trocar of accepting diameter or via an incision in the skin, and exit extracorporeally via another trocar (for example, of larger diameter at umbilicus), whereupon the grasper may open its and receive the lysing tip at an angle that permits the grasper to pull lysing tip into the body cavity through the larger trocar. Once inside the body cavity, the lysing tip may be reconfigured from a delivery configuration to a treatment configuration.
Lysing tip1710 may comprise a plurality ofprotrusions1701 comprisingbeads1751 andrecessions1702 between each bead pair.Lysing member1760, which in the depicted embodiment comprises a lysingrod1760 enclosed byspacers1762a/1762b/1762cpositioned inrecessions1702, delivers electrosurgical energy. Each of the portions of lysingmember1760 extending betweenadjacent beads1751 may be considered lysingsegments1760a/1760b/1760c. In the depicted embodiment, each of the lysing segments orspacers1762a/1762b/1762cis collectively defined by asingle lysing member1760. However, other embodiments are contemplated in which separate lysing members may be used for each of the lysing segments positioned between adjacent beads.FIG.17cdepicts lysingtip1710 withbead1751cremoved in order to show internal components and to show tunneling withinouter beads1751aand1751d.
InFIG.17j,spacers1762a/1762b/1762cmay be removed and replaced withprotuberances1765a/1765bpositioned on opposing sides of one or more of the beads, such asmiddle bead1751b, as a means to inhibit or limit the lateral movement ofmiddle bead1751band/or any other beads, as desired. Additionally depicted inFIG.17jis an embodiment in whichlysing rod1760 is roughened or otherwise deformed betweenpoints1767L and1767R. In some such embodiments, this may be done by adding material to the lysing rod and/or adding material to the inside of thebead tunnel1754 in a manner that the diameter of sufficient portions of lysingrod1760 is increased to or slightly greater the internal diameter oftunnel1754 ofbead1751csuch that whenbead1751cis slid into its position betweenpoints1767L and1767R,bead1751cmay tend to remain in place via friction fit. Alternatively, the portions of lysingrod1760 configured to extend throughbead tunnel1754 may be roughened by removing material from lysingrod1760 such as by sanding and/or blasting. In these configurations, lysingrod1760 may also act as the lysing segments. InFIG.17j. although both protuberances and friction fit are shown and spacers removed, this is done primarily for purposes of illustration, thus, as those of ordinary skill in the art will appreciate, in practice, only one of the options may likely be used. The roughening described herein may be useful for example in order to prevent or inhibit rotation of the beads on the lysing rod. In some embodiments, the amount of roughening may be used selectively to select the amount and/or ease of rotation.
In alternative embodiments,hole1055d′ may be moved to fully or partially intersecttunnel1054 thus allowing communication with lysingrod1060; thus a weld, plug (for example1055p), glue, insert or other method of fixation may be inserted viahole1055d′ to attach to lysingrod1060 thus restricting lateral movement of a bead. To reduce escape of electrosurgical energy throughhole1055d′, an insulator comprised of epoxy, plastic, ceramic or the like may be placed in part or all of the remaininghole1055d′. This alternative embodiment may be applied to other embodiments herein.
FIG.17killustrates a front/elevation view of an alternative embodiment in whichlysing tip1710 may be configured without a solid lysing rod and/or without spacers and/or welds (that may face distally, proximally, or therebetween) and the like. In such embodiments,internal bead tunnels1754 andsupport member holes1767a/1767bmay be configured to accommodatehollow lysing rod1760a. Between beads,hollow lysing rod1760amay be deformed1760a′ in a manner to prevent lateral movement of beads and/or prevent rotation of beads, as shown inFIG.17k. Hollow lysingrod1760a′ may be deformed minimally or to a point that it is substantially flat. In such embodiments, it may be preferable for the front edge to point distally as the leading front edge. In such embodiments,screw1709 may secure one or both ends of thehollow lysing rod1760awithinouter beads1751a/1751d. In alternative embodiments,hollow lysing rod1760amay be replaced withsolid lysing rod1760 and deformed adjacent to middle beads in the manner suggested in this paragraph. The configurations of this alternative embodiment may be available for any other similar embodiment contemplated herein.
In alternative embodiments that may comprise lysingrod1760,spacers1762a/b/cmay be deformed on the lysingrod1760 so as to become immovable, either in addition to deforming the lysing rod itself or as an alternative to deforming the lysing rod.
As previously mentioned,beads1751 may be coupled with one another by way of asingle lysing member1760 extending throughtunnels1754 extending through each of therespective beads1751. In the depicted embodiment,beads1751 each comprise a non-symmetrical shape and/or may be eccentric relative totunnels1754. However, in this embodiment, as shown in the figures, the opposingouter beads1751aand1751dhave a shape that differs from the shape of the beads in between the outer beads, namelybeads1751band1751cOf course, as previously mentioned, in some embodiments, all of the beads may have the same, or substantially the same, shape/size. In other embodiments, each of the beads may have a different shape to accommodate a particular type of surgery, for example. More particularly,beads1751band1751chave a similar distal or frontal shape (from the perspective of the treatment side of tip1710) but have a flattened, thus shorter, rear end so as to accommodate asupport member1770, which in this embodiment comprises abow1770. Support member, as described in greater detail below, may be used to facilitate temporary coupling of lysingtip1710 to a surgical tool, such as a driver. In some embodiments,support member1770 may also be used to facilitate delivery of electrosurgical energy into lysingtip1710.Support member1770 may be preferably fully or partially insulated, except for regions on which it is desired to transfer electrosurgical energy such as (1) at one or more surfaces of graspingpad1771, (2) within the 2 distal support member holes (as shown inFIG.17e,1767a/1767b), and/or (3) the opposing distal ends ofsupport member1770, in some cases distal of lysingrod1760 in order to deliver electrosurgical energy not only through lysingrod1760 but also through these distal ends ofsupport member1770.Support member1770 may be fully or partially insulated in order to prevent electrosurgical energy from transferring to tissue from thesupport member1770; more particularly, insulatingsupport member1770 directs electrosurgical energy to lysingmember1760 throughsupport member holes1767a/1767b. In some embodiments,support member1770 may comprise for example a non-conductive material such as a ceramic and/or flexible ceramics (for example, “Flexiramics®”). In some such embodiments, one or more electrical conduits such as a wire may be embedded within and/or extend through or otherwise be coupled with thesupport member1770 so as to deliver electrosurgical energy to lysingmember1760.
Support member1770 may be used to provide a frame or support structure for lysingtip1710 and/or used to provide a feature, such asgrasping pad1771. In the depicted embodiment, thegrasping pad1771 is defined in part by atab1771a, to allow an endoscopic tool having a grasping tip, such as graspingtip jaws1796a/1796bof grasping/control instrument1790, to grasp and manipulate lysingtip1710. If the tip ends ofsupport member1770 are coated with nonconductive insulation, such coating might increase the width ofrelative protrusion1701 and perform similar to a protrusion bluntly dissecting/separating tissues, however, if said tips are not so coated, the area ofrelative protrusion1701 may be limited to what is illustrated as said tip may perform in a manner similar to lysingrod1760 cutting and/or coagulating tissues.
Support member1770 in the current embodiment comprises a bow shape comprising two opposing end tips comprising holes or other openings through which lysingrod1760 extends. The two tips ofsupport member1770 may extend far enough distally to provide sufficient material to form the lysing rod through-holes. Alternatively, openings comprising slots or the like may be formed at one or both of the two opposing tips ofsupport member1770 if desired.
In the depicted embodiment, thetunnels1754 are positioned in a non-central location within each ofbeads1751. More particularly, thetunnels1754 in this particular embodiment are positioned in a forward or distal location relative to a central axis of each ofbeads1751, includingouter beads1751aand1751d, which may have a ellipsoidal or similar shape, andinternal beads1751cand1751d, which may have a similar ellipsoidal front tip but have a flattened and/or shortened rear end, as shown in the figures. As previously mentioned, this may be preferable for some embodiments, particularly embodiments in whichbeads1751 can at least partially rotate on the lysing rod or other lysingmember1760 to allow thelysing tip1710 to be directed through tissue in a desired manner.
Preferably, the entire surfaces of thebeads1751, or at leastouter beads1751aand1751d, may be smooth. Or, at least all surfaces that may be expected to contact tissue during a surgical procedure may be smooth. For example, providing a smooth front end and a smooth trailing end may allow the lysing tip to be moved in a forward direction and then in a rearward direction back and forth without catching an undesirable amount of tissue on beads to inhibit such movement. However, as shown inFIGS.17a-17m, in some embodiments, the trailing end of some beads, such asinternal beads1751band1751c, may comprise a flat surface such that each internal bead comprises a frusto-shaped or another similar shape. In other contemplated embodiments, providing a rough trailing end may create frictional drag on that portion of the bead thus helping reorient the front end of the bead for further tissue passage. Thus, in some embodiments, the trailing end may have a rougher surface than the front end. Preferably, at least the forward or distal surface of each bead is smooth and defines a substantially and/or partially ellipsoidal shape or another shape having a smooth forward surface. In alternative embodiments, the distal/forward tip ofbeads1751 may have a more narrowed end to act more as a wedge for purposes of acting as a blunt dissector between tissues and tissue planes. The forward tips may be narrowed by use of facets (such as thosefacets1052 inFIG.10d). Facets are preferably formed on the distal/front/leading portions of the bead to facilitate tip movement through/between tissue layers. As described inFIGS.12aa-rr, a wide variety of alternative bead shapes are possible including, for example, ovoid shapes, spherical shapes, wheel shapes, bullet shapes or other shapes having a flat terminal end (such as, for example, frusto-ellipsoidal), wing shapes, etc. In some embodiments, beads may be faceted on the top, bottom, sides, front and/or back such as illustrated inFIGS.10c/10d, atfacet1052.
As previously mentioned, in some embodiments, it may be desirable to allowbeads1751 to rotate, at least partially, on lysingmember1760. Thus,beads1751 may not be fixed three-dimensionally with respect to lysingmember1760 and/or one or more other elements of lysingtip1710. In some such embodiments,beads1751 may be at least partially rotatable with respect to the remainder of lysingtip1710. In embodiments in whichbeads1751 are rotatable in this manner, it may be desirable to use a lysing member having a circular cross section. It may also be desirable to formspacers1762a/1762b/1762cin ways that facilitate such rotation and/or restrict it in some manner. Thus, in some embodiments, one or more ofspacers1762a/b/cmay also be rotatable with respect to lysingmember1760. In some such embodiments,spacers1762 may be configured to rotate withbeads1751.
In the depicted embodiment, each of thespacers1762a/b/cis positioned about one of the respective lysing segments defined by lysingmember1760 which may be configured to space thevarious beads1751 apart, provide stability to the lysing tip, and/or protect the respective lysing segments (which, in the depicted embodiment, are collectively defined by a single lysing member1760). Preferably,spacers1762a/b/ccomprise a conductive material, such as a suitable biocompatible metal, that can receive electrosurgical energy from the lysingmember1760 and deliver it to various internal body tissues during a surgical procedure. Preferably, spacer(s)1762a/b/care therefore in direct contact in one or more pre-determined locations on lysingmember1760. In other embodiments, a single spacer may both extend between thevarious beads1751 and extend through the tunnels through thebeads1751 rather than using separate spacers for each lysing segment.
One or more of thebeads1751, such as preferably one or both of theouter beads1751aand1751d, may further comprise ahole1755. Hole(s)1755 may, together with a cord1744 (which may be a suture), for example, comprise an example of means for maintaining retrievability of a free-floating lysing tip when the lysing tip is decoupled from a grasping/control instrument. In preferred embodiments and/or implementations,cord1744 or another loopable element may be looped through one or more such hole(s) and then may extend through one or more cannulas used to deliver lysingtip1710 proximally back to a surgeon. In this manner, in the event of a failure to grasp or otherwise couple lysingtip1710 to a grasping/control instrument, such as grasping/control instrument1790, lysingtip1710 may be retrieved from within a patient's body by pulling onsuture1744 to retract lysingtip1710 thoughcannula1732. In some embodiments,hole1755 may also or alternatively be used to maintain position of lysingtip1710 while awaiting delivery of a grasping/control instrument1790 for performing surgical procedures. Upon properly coupling lysingtip1710 with an appropriate tool for grasping and/or controllinglysing tip1710, such as grasping/control instrument1790, a surgeon may cutsuture1744, preferably near a knot or other feature used to form a loop aroundhole1755. If asuture1744 or other similar material/element is used that is sufficiently flexible and non-disruptive, this shorter loop may be configured to be present during a surgical procedure usinglysing tip1710 without unduly interfering with the procedure. In alternative embodiments,holes1755 may be available as a platform/location to add other features/components such as providing a location for coupling of a cord as described below in connection with other embodiments and/or locating a sensor and/or RFID location component and/or being used for placement of luminescent and/or light production element(s) for visualization, for example, tritium and the like. In alternative embodiments,hole1755′ may be moved to fully or partially intersecttunnel1754 thus allowing communication with lysingrod1760; thus a weld, plug, glue, insert or other method of fixation may be inserted viahole1755′ to attach to lysingrod1760 thus restricting lateral movement of a bead and/or rotation of the bead with respect to lysingrod1760. However, in some embodiments one or more of the beads along with the lysingrod1760 may be configured to rotate at least partially with respect to thesupport member1770. To reduce escape of electrosurgical energy throughhole1755′, an insulator comprised of epoxy, plastic, ceramic or the like may be placed in part or all of the remaininghole1755′. This alternative embodiment may be applied to other embodiments herein.
Preferably, lysingmember1760 terminates withinouter beads1751aand1751d. Thus, it may be desirable to melt, tip, ball, crimp, fold, tie, or otherwise couple the ends of lysingmember1760 withinouter beads1751aand1751dat opposing lysingmember coupling tips1763aand1763b. Preferably, lysingtip1710 is configured such that each ofbeads1751 are rotatable independent of one another. However, depending upon how opposing lysingmember coupling tips1763aand1763bare configured, rotation ofouter bead1751amay transfer, at least to a certain extent, toouter bead1751d, and vice versa.
In some embodiments, it may be desirable to provide features and/or elements that inhibit or limit the ability of the electrosurgical energy to discharge from the opposing ends of the lysingrod1760 atcoupling tips1763a/b. Thus, in some such embodiments,coupling tips1763a/bmay be coated or covered with a suitable insulating material such as an epoxy with non-conductive properties. Alternatively,outer bead hole1754 at the end with the larger-opening may be capped or plugged with an element configured to be received or otherwise engage the larger opening of the bead. Preferably, this element will have non-conductive properties similar to the insulating material previously referenced.
Coupling tip1763a/1763bmay be configured to engage aledge1759 positioned at a transition point between two concentric tunnels (1759a/1759b), more particularly,outer tunnel1759bmay comprise a larger diameter or other cross-sectional dimension thaninner tunnel1759asuch that lysingmember1760 may extend throughinner tunnel1759abutcoupling tip1763adue to its larger size may be configured to extend throughouter tunnel1759bwithout passing throughinner tunnel1759a. In other embodiments, there may be asingle tunnel1759cthat tapers from a larger dimension on the outer side ofbead1751 to a smaller dimension toward the inside of the bead relative to thelysing tip1710.
As shown inFIG.17a, graspingpad1771 ofsupport member1770 may be situated along a central portion ofsupport member1770 along the rear or proximal end of lysingtip1710. In some embodiments, graspingpad1771 may comprise a plate with opposing flattened surfaces configured to allow a surgical tool with a grasping tip, such asjaws1796aand1796binFIGS.17fand17g, to grasp and/or manipulate/control support member1770 and therefore lysingtip1710.
In some embodiments, at least a portion ofsupport member1770 and/or graspingpad1771 may comprise a conductive material andsupport member1770 and/or graspingpad1771 may be configured to receive electrosurgical energy, such as from a grasping/control instrument1790 or another surgical tool, and deliver such energy to lysingmember1760. For example, in some such embodiments, electrosurgical energy may be delivered through grasping jaws1793a/1793b, into graspingpad1771, down through the frame ofsupport member1770, and into lysingmember1760. In other embodiments, graspingpad1771 may be insulated and electrosurgical energy may instead be delivered to lysingtip1710 in another manner.
FIGS.17a-eillustrate atab1771aextending distal from graspingpad1771, which comprises an extended central region. Such central region may be useful to allow for greater surface area for grasping by jaws or other elements of a grasping tip from a surgical tool, such asjaws1796a/1796bof grasping/control instrument1790.
In embodiments comprising a free-floating lysing tip (can be uncoupled from any control instrument or cannula), including the embodiments ofFIGS.17-31 and35-38, certain preferred embodiments may have a size of about 12 to 18 mm from the end of one protrusion and/or bead to the opposite protrusion/bead on the opposite end; the length of the largest outer beads (BL as illustrated inFIGS.10d/10e) may range from about 3 mm to 12 mm; the height BH as illustrated inFIGS.10d/10e) of the largest outer beads may range from 2 mm to 10 mm. In some embodiments, this dimension may be defined by the distance from the upper end of one or more (in some embodiments, each) beads to the lower end of one or more beads. In some free-floating embodiments, the lysing tip may have a width TW as illustrated inFIGS.10d/10e) of about 4.5 mm from the proximal end of the lysing tip to the distal end of the lysing tip. However, it should be understood that a wide variety of alternative shapes and/or sizes may be usable depending upon the particular surgical procedure involved.
Similarly, in embodiments comprising a fixed lysing tip (coupled to one or more actuation rods), certain preferred embodiments may have a size of about 15 mm from the end of one protrusion and/or bead to the opposite protrusion/bead on the opposite end, may have a size of about 3 mm from the upper end of the lysing tip to the lower end of the lysing tip. In some embodiments, this dimension may be defined by the distance from the upper end of one or more (in some embodiments, each) protrusions/beads to the lower end of one or more protrusions/beads. In some free-floating embodiments, the lysing tip may have a size of about 3.5 mm from the proximal end of the lysing tip to the distal end of the lysing tip. However, it should be understood that a wide variety of alternative shapes and/or sizes may be usable depending upon the particular surgical procedure involved.
InFIGS.17h-i, anon-conductive sheath1795 may be deployed to cover the outer surface and/or conductive surfaces of shaft and tip/jaws1793a/1793bof grasping/control instrument1790 to electrically isolate the electrically conductive surfaces of grasping/control instrument1790. In the current embodiment,conducting wire1768 may carry electrosurgical energy from the energy source to lysingtip1710. In other embodiments, the embodiment ofFIG.17h/17imay also have an insulatedgrasping pad1771, sincewire1768 is provided for delivery of electrosurgical energy. In other contemplated embodiments,sheath1795 may electrically isolate the grasping control instrument, but permit electrical contact between the jaws of graspingcontrol instrument1790 and the grasping plate of lysingtip1710. However, it should be understood that the shape of graspingpad1771 may be used in conductive or non-insulated embodiments.
FIG.17bis a cross-sectional view taken alongline17b-17binFIG.17aillustrating spacer1762b, middle bead,1751b,support member1770, and lysingrod1760.FIG.17eis a perspective view of support member1770 (and grasping pad1771) comprisingholes1767a/1767bthrough which lysingrod1760 extends and comprisescoupling tips1763a/1763bon its opposing ends.
An alternative system for use of alysing tip1714twith a modulargrasping instrument tip1714gis shown inFIGS.17L and17m. In some embodiments,modular instrument tip1714gand lysingtip1714tmay be permanently coupled to one another as described below. Alternatively, in otherembodiments lysing tip1714tmay be removable frommodular instrument tip1714g. When theinstrument tip1714gand lysingtip1714tmay be combined, they may be referred to herein as a modular grasper/tip1714.Modular instrument tip1714gcomprises alocking lumen1799′ that is configured to be coupled with a distal end of apushrod1797 andshaft1796 of a modular grasping/control instrument90.
In an example of a procedure using the system ofFIG.17L, a surgeon may initially place atrocar1732′ at a desired location such as through anincision6′ positioned through theumbilicus5. Asecond incision6, which may be a smaller incision thanincision6′, may be made at a location spaced apart fromincision6′. In some embodiments and implementations,incision6 may be between about 2.5 and about 5 mm.Shaft1796 ofinstrument90 may then be extended throughincision6 and then subsequently throughincision6′ andtrocar1732′. Modular graspinginstrument1714gmay then be coupled with the distal end ofshaft1796 and pushrod1797. Once lysingtip1714tis coupled with modulargrasping instrument tip1714g,instrument90 may then be pulled proximally to introduce lysingtip1714twithinpatient4. In embodiments in whichlysing tip1714tis removable from modular graspinginstrument tip1714g, lysingtip1714tmay be coupled with the distal end ofinstrument tip1714gprior to proximally pullinginstrument90 and its distal tip back into the cavity of human oranimal body4. Oncemodular instrument tip1714ghas been coupled withinstrument90, handle91 may be used to control one or more aspects of lysingtip1714t. For example, actuation ofhandle91 may result in lockinglysing tip1714tat a particular rotational orientation relative toshaft1796 as described in connection withFIG.17M. Alternatively, handle91 or another actuation element ofinstrument90 may be used to rotate lysingtip1714tbetween delivery and treatment configurations.Instrument90 may also be used to deliver electrosurgical energy to lysingtip1714t. For example, as shown inFIG.17L,energy connector92 which may comprise a conductive post may be used to facilitate an electrical connection with an electrosurgical generator. The electrosurgical energy from this generator may extend throughshaft1796 viapushrod1797 and be coupled with one or more lysing members of lysingtip1714tas previously described.
FIG.17M depicts a more detailed view of the interface between modulargrasping instrument1714gand distal tip ofshaft1796 andpushrod1797 ofinstrument90. As shown in this figure the distal end ofshaft1796 may comprise alocking feature1798.Locking lumen1799′ within modularinstrument tip shaft1794 comprises aslot1799sconfigured to receivelocking feature1798 at a predetermined rotational configuration. Upon aligninglocking feature1798 withslot1799s,shaft1796 andpushrod1797 may be advanced intolocking lumen1799′. After advancingshaft locking feature1798 to itsterminal end1798′ withincoupling rod1792, upon rotation2 of modularinstrument tip shaft1794, lockingfeature1798 securely couplesshaft1796 tocoupling rod1792. During the same time period,pushrod1797 and its accompanyingpushrod locking feature1799nwas advanced to alocking chamber1799n′ in whichpushrod1797 and its accompanyingpushrod locking feature1799nmay have been rotated to lockpushrod locking feature1799nin place within lockingchamber1799n′. In some embodiments, the extent of the rotation ofpushrod locking feature1799nmay be the same as the extent of rotation of lockingfeature1798 which may in some embodiments be 90 degrees. In some embodiments,pushrod locking feature1799nmay comprise a plate or an elongated box or any other feature not having rotational symmetry about theaxis pushrod1797. Lockingchamber1799n′ may comprise for example a box or other similar feature given to engagepushrod locking feature1799nupon rotation ofpushrod1797.
Lockingchamber1799n′ is coupled withcoupling rod1792 which in turn may be coupled with one or both jaws. Thus, upon advancing or retractingpushrod1797,coupling rod1792 advances or retracts to open or close the jaws so as to capturesupport member1770 within jaws1793a(not shown)/1793b.
Any of the preliminary steps for coupling a lysing tip with an instrument and/or inserting the lysing tip into a patient discussed in connection withFIGS.17L and17mmay be performed in connection with any of the surgical methods described in connection withFIGS.40-50.
FIGS.18a-18edepict another embodiment of a CDTD system or a non-CDTD system. Although, other embodiments are contemplated in whichsystem1800 may comprise a CDTD system.System1800 comprises alysing tip1810 that is configured to be completely separable from any other element of the system.Lysing tip1810 may comprise a plurality of protrusions1801 comprisingbeads1851a-dandrecessions1802 between each bead pair. Lysingmember1860, which in the depicted embodiment comprises alysing rod1860, is enclosed or may be partially enclosed byspacers1862a/1862b/1862cpositioned inrecessions1802, delivers electrosurgical energy. Each of the portions of lysingmember1860 extending betweenadjacent beads1851 may be considered lysing segments as discussed previously herein. In the depicted embodiment, each of the lysing segments orspacers1862a/b/cis collectively defined by a single lysingmember1860. However, other embodiments are contemplated in which separate lysing members may be used for each of the lysing segments positioned between adjacent beads. Spacers may be configured and/or attached as described and illustrated inFIGS.18a-18eto immovably fixspacers1862a/b/con alysing rod1860.
Spacers1862a/1862b/1862cmay be coupled withlysing rod1860 by, for example, slidingspacers1862a/b/ccomprising a lumen along the axis of lysingrod1860. Alternatively,spacers1862a/b/cmay be coupled withlysing rod1860 by placingspacers1862a/b/cover lysingrod1860 in a direction perpendicular to the axis of the lysing rod at a desired location using a slot or other opening formed along a portion of aperimeter spacer1862a/b/c. In some embodiments and implementations,spacers1862a/b/c(two of a potential three shown inFIG.18c) may be crimped or otherwise fixedly coupled with lysingrod1860 at a desired location. In some embodiments, this fixed coupling may be configured to prevent the relative movement betweenlysing rod1860 andspacer1862a/b/cpossibly reducing hot spots caused from high current density flow in certain areas between lysingrod1860 andspacer1862a/b/c. These exemplary methods for applying spacers to a lysing rod and/or another lysing member may be apply to any of the other embodiments utilizing spacers.
In some contemplated embodiments spacers may be comprised of insulating materials (such as ceramic, glass, plastic and the like) that may have holes and/or be porous and/or have breaks and/or have separations such that energy from lysing member(s) within may be released into target tissues to have effect such as that illustrated inFIG.12j.
In some such embodiments,beads1851 may be at least partially rotatable with respect to the entirelysing tip1810. In embodiments in whichbeads1851 are rotatable in this manner, it may be desirable to use a lysing rod having a circular cross section. It may also be desirable to eitheromit spacers1862a/b/cor form them without the beveled edges best shown inFIGS.12h,12n, etc.
Spacers1862a/b/cmay be used to prevent rotation ofbeads1851 or to selectively limit the amount of rotation ofbeads1851 on a lysingmember1860. For example, ifspacers1862a/b/cextend the entire distance or at least substantially the entire distance between each adjacent bead, spacers may prevent rotation or, depending upon the distance between spacers and adjacent beads, may be used to allow for a predetermined amount of such rotation. Similarly, the opposing ends ofspacers1862a/b/cmay be shaped to match or at least substantially match the shape of the adjacent bead(s) again to either prevent or control rotation.
System1800 differs fromsystem1700 only in the manner as to how lysingtip1810, specifically at graspingplate1871, is grasped by grasping/control instrument1890. Specifically, inFIGS.18a-e, the grasping/control instrument1890 comprises a tip withupper jaw1893aandlower jaw1893b, configured in such a manner to create, when shut, a receivingslot1897 into which the graspingpad1871 ofsupport member1870 may be grasped. The dimensions of thereceiving slot1897, such as the width and/or height of receivingslot1897 may correspond with the dimensions of thesupport member1870 at itsgrasping pad1871 such that there will be a rigid coupling between the jaws and support member during the surgical procedure.FIG.18dillustrates ledge1859 withinbead1851 which may engage coupling tips positioned on opposing ends of lysingrod1860.Support member1870 may be preferably insulated, except within its holes, to prevent unwanted delivery of electrosurgical energy to tissues; thus, electrosurgical energy is directed to support member holes at which lysingrod1860 becomes energized for energy delivery.
In this embodiment,facets1852 may be positioned at the distal ends of the beads and the configuration of the tunnels in the end beads may capture corresponding elements as described in previous embodiments. For example, certain beads may comprisehole1855 that may be positioned perpendicular to lysingrod hole1858;holes1855 may be available as a platform/location to add other features/embodiments (for example,antennae1847 and/or sensor1848) and/or to be used for cord/suture attachments for lysing tip manipulation and/or removal and/or be used for placement of luminescent and/or light production for visualization, for example, tritium and the like.
This description is intended to apply to holes in other embodiments herein similar to1855.
InFIGS.19a-d, an alternative structure for thesupport member1970 oflysing tip1910 is depicted, however, all other features of the embodiments depicted in allFIG.17 andFIG.18 may be the same in regards to or may apply to the embodiment depicted inFIG.19. InFIG.19,support member1970 comprises agrasping pad1971 withtab1971a, however, in the depicted embodiment,grasping pad1971 comprises an opening1973 which may be either a blind hole or a through-hole.Opening1973 may be configured to receive acorresponding projection1996aformed on one or both of jaws of the tip of a grasping/control instrument, such as that inFIG.19b,jaws1993a/1993b, to facilitate a secure coupling during the surgical procedure. In addition,corresponding projection1996amay be used to deliver energy from grasping/control instrument1993 directly to the opening1973 ofsupport member1970 which may be especially beneficial ifjaws1993a/1993bandgrasping pad1971 are coated with non-conductive insulation andprojection1996aand the tunnel of opening1973 are not so coated with a non-conductive coating. Thus, in someembodiments projection1996amay comprise a conductive, uncoated projection protruding from coated jaws.
InFIGS.19cand19d, an alternative embodiment of a non-CDTD system is illustrated comprisinginner beads1951iandouter beads19510 coupled with a bow/support member1970 and further comprising an energy window made up of a plurality ofelectrode termini1906 for delivering energy such as RF. This embodiment is similar to that depicted inFIG.15a-k. In some embodiments the RF energy delivered by thetermini1906 may be distinct from the RF energy delivered by the lysing segments between the adjacent beads. More particularly, in the depicted embodiment, the energy window comprises anenergy window strip1907 which is preferably made of a conductive material.Energy window strip1907 comprises a plurality ofenergy window termini1906 protruding from theenergy window strip1907. Aninsulation cover1908 may be configured to be coupled withenergy window strip1907. In someembodiments insulation cover1908 may be molded ontoenergy window strip1907. Alternatively theinsulation cover1908 may be configured to receive theenergy window strip1907 or otherwise be coupled withenergy window strip1907. Preferably, theinsulation cover1908 comprises a non-conductive material. In the depicted embodiments, theinsulation cover1908 comprises an elongated base configured to cover the energy window strip but allow theenergy window termini1906 to protrude through theinsulation cover1908. In addition, theinsulation cover1908 comprises a plurality of protruding bead coupling members (not shown here, but as depicted inFIG.15h,bead coupling member1508′), each of which is configured to extend into and be coupled with one of the beads of the tip via hole1955o(as shown inFIG.15i, a cross-sectional view down/through the center ofouter bead1551d).Energy delivery conduit1909 such as a wire may be coupled with theenergy window strip1907. Preferably, theenergy delivery conduit1909 is insulated from the energy delivery conduit that delivers energy to the lysing segments such that a distinct type of energy may be delivered therethrough.
In other embodiments, the energy windows may be configured to utilize energy of different modalities, including, but not limited to, laser, intense pulse light, resistive heating, radiant heat, thermochromic, ultrasound, mechanical, and/or microwave.
In alternative embodiments, theenergy window strip1907 may be configured to be positioned on the bottom of the device, thus mounted on the bottom ofbeads1951i/1951o. However, in various implementations, a surgeon may simply invert the tip of a top-mountedenergy strip1907 so that it points in the opposite direction (for example, away from the surface skin and toward the subcutaneous tissues. This inward/subcutaneous direction of energy may be useful in directing energy toward the subcutaneous deposits in cellulite and other cosmetic conditions.
FIGS.20a-20odepict another embodiment of a CDTD or non-CDTDsystem2000.System2000 comprisesprotrusions2001 andrecessions2002.System2000 comprises alysing tip2010 that is configured to be completely separable from any other element of the system, however, lysingtip2010 is configured to work in conjunction with the substantially ellipsoidal-shape at the distal end ofjaws2093a/2093bof grasping/control instrument2090, as this preferably insulated shape may serve the same functions asbeads2051a/2051bas previously discussed. Lysingtip2010 comprises twobeads2051a/2051bpositioned at opposite end of lysingmember2060. In the depicted embodiment, lysingmember2060 comprisesplate2060 which may comprisegrasping pad2071. Upon being grasped by grasping/control instrument2090 to perform a surgical procedure, thedistal tip2093 of grasping/control instrument2090 substantially mimics the shape and/or function ofbeads2051a/2051bsuch that two lysing segments are defined on opposite ends betweentip2093 and bead2051aon one side and betweentip2093 and bead2051bon the other. In some embodiments, the portion ofdistal tip2093 extending onto or beyondlysing plate2060 may have an identical or at least similar distal shape and size to beads2051a/2051b. For example, this portion ofdistal tip2093 may have rounded/smooth surfaces that taper towards a rounded tip similar to beads. At the very least, it is preferred thatdistal tip2093 be shaped and sized such thatlysing plate2060 can come in contact with or near contact with target tissues. Together, thebeads2051a/2051banddistal tip2093 may function as blunt dissectors to separate tissues without cutting. While the device is energized with electrosurgical energy,beads2051a/2051band outer surfacedistal tip2093 are preferably non-conductive in order to perform the blunt dissection function. The inside ofjaws2093aand/or its correspondinglower jaw2093bdefine areceiving slot2097 and one or both may be electrically conductive in order to permit electrosurgical energy to flow to thelysing plate2060.
System2000 is configured to prevent or limit lateral movement ofouter beads2051 byfixing bead holes2053a/2053binouter beads2051a/2051band correspondinglysing plate holes2066a/2066bthrough which a resulting substantially solid object like a pin or glue may be inserted to effectively couple thebeads2051 to thelysing plate2060. In alternative embodiments,lysing plate holes2066a/2066bmay be replaced with grooves that may receive the solid object(s) inserted through fixing bead holes2053.
In alternative embodiments, the dimensions ofplate2060 may be reduced to approach the width and/or thickness of previously described lysing rods. In such embodiments, the corresponding tunnel inouter beads2051a′/b′ may be appropriately reduced to match corresponding dimensions and/or the corresponding grooves and in one or more of thejaws2093a′/2093b′ of the grasping instrument may similarly be modified to match that of at least a portion ofrod2060′. In alternative embodiments as shown inFIG.20o,upper jaw2093a″ may consist of a front portion that overhangs truncatedlower jaw2093b″, thus reducing the possibility of tissue entry on forward motion. In other embodiments, the overhang may encompass a larger portion of the opposite jaw. In this depicted embodiment,jaws2093a″/2093b″ are configured such that despite the previously described overhang ofupper jaw2093a″, when the jaws are in a closed configuration, the distal portion of theinstrument2090′ substantially mimics the shape about the distal portions of the beads about the distal portion of theinstrument2090′.
In some embodiments, lysingmember2060′ comprises a rigid and/or substantially rigid wire as shown inFIGS.20i-20o. In such embodiments, one or both ofjaws2093a″ and2093b″ may comprise a slot configured to receive the rigid wire/lysing rod2060′. Thisslot2097′ may be configured so as to tightly receive lysingrod2060′ so as to prevent or at least inhibit rotation of lysingtip2010′. Alternatively,slot2097′ may either be slightly larger than the diameter of lysingrod2060′ or may be configured to allow a user to adjust the size ofslot2097′ by actuating one or both ofjaws2093a′/2093b′ such that the user can provide for a desired amount of rotation corresponding with the force delivered tojaws2093a′/2093b′. As previously mentioned, other features may be included to limit or selectively allow for rotation such as welds and/or spacers (for example, spacer2062′ extending from inside each outer bead orspacer2062″ coupled to lysingrod2060′ extending from side of outer bead to side of graspingjaw2093a″/b″). For example, in some embodiments, spacers may be positioned adjacent to opposingouter beads2051a′/b′ such thatjaw2093a′/b′ may grip lysing rod2070′ in between the two spacers. Such spacers may be used to either inhibit or selectively limit rotation by, for example, their shape, and/or proximity tojaws2093a′/b′. In this embodiment, a surgeon may be able to dissect on one or more of the sides on the backstroke, possibly making surgery more efficient. In some preferred embodiments and implementations, allowing for reverse dissection, it may be preferable to either loosen the grip of the lysing rod or otherwise provide for a coupling between the jaws that is loose enough allow for rotation the lysing rod within the jaws. Alternatively, a rigid coupling between the lysing rod and the jaws may be provided and instead the beads may be configured to rotate about the lysing rod such that the distal ends of the beads become the proximal ends when the lysing tip is being reversed.
In alternative embodiments, lysingrod2060′ may not be end capped at the exact outermost portions of its tips. Instead any number ofholes2055′ may be made at any number of angles to intersect the lysingrod2060′ and/or itstunnel2054 or2054′ to deposit a material that restrains the lysing rod within thebead2051a′/b′ (for example, materials may include welds, glues, epoxies, plugs (2055p), and the like). In such embodiments,tunnel2054′ may be a blind tunnel not requiring full passage throughbead2051a′/b′ as bead may be fixed/restrained internally. See for exampleFIGS.20j/kshowing side views ofbeads2051a′ and2051a″.FIG.20kshows full passage oftunnel2054 which intersects withhole2055′ (illustrated with dashedlines designating hole2055′ being internal to bead2051a′).FIG.20jillustratestunnel2054′ (illustrated with dashed lines) which intersects withhole2055′ (illustrated with dashedlines designating hole2055′ being internal to bead2051a″) not extending to the outside ofouter bead2051a″. This alternative embodiment may be applied to other embodiments herein. In alternative embodiments,beads2051a′/b′ may be replaced with beads of any shape, including but not limited to those depicted inFIGS.12aato12rr. In some embodiments wherein a spacer is positioned between a lysing rod and grasper jaws, the tolerance between the lysing rod and a spacer may allow for rotation of the lysing rod within the spacer and thus allow for rotation of beads with respect to a spacer and/or grasper. The tolerance may be adjusted to allow for a predetermined amount of rotation.
In the embodiment illustrated inFIGS.21a-e, thelysing tip2110 comprises graspingplate2161, lysingrod2160, andbeads2151a/2151b. In this embodiment the inner surfaces ofupper jaw2193aandlower jaw2193b(of grasping/control instrument2190) are configured to match or substantially match the upper and lower surfaces of graspingplate2161 in the closed configuration (thus creating receiving slot2197). The lysingrod2160 may be permanently or temporarily coupled to graspingplate2161 for example by weld, and/or by snap-fit between the distal end of thegrasping plate2161 and the center/proximal portion of lysingrod2160. In the depicted embodiment, the width of the grasping plate tapers from a widened portion of the proximal end to a narrowed portion of the distal end which tapering may mimic or substantially mimic similar tapering of thecorresponding jaw2193a/2193b. The length of graspingplate2161 may be similar to or identical to the length of one or bothjaws2193a/2193b. In some embodiments, the outer surfaces ofjaws2193a/2193bmay be surface-coated with a non-conductive dielectric coating.
Lysing tip2110 may comprise a plurality ofprotrusions2101 comprising distal portions ofbeads2151 andrecessions2102 between each bead pair. The portions of lysingmember2160 extending betweenadjacent beads2151a/2151bmay be considered the lysing segment.
As previously mentioned,beads2151 may be coupled with one another by way of asingle lysing member2160 extending throughtunnels2154 extending through each of therespective beads2151. In the depicted embodiment,beads2151 each comprise a non-symmetrical shape and/or may be eccentric relative totunnels2154. More particularly,tunnels2154 are positioned distally of a central portion ofbeads2151 such that there is more material proximally oftunnels2154 than distally.Beads2151aand2151bhave a similar distal or frontal shape (from the perspective of the treatment side of tip2110) but have a flattened, thus shorter (from the elongated-axis perspective),rear end2153a. In other embodiments, beads may have a greater elongated-axis dimension.
As previously mentioned, this may be preferable for some embodiments, particularly embodiments in whichbeads2151 can at least partially rotate on the lysing rod or other lysingmember2160 to allow thelysing tip2110 to be directed through tissue in a desired manner. In some contemplated embodiments, beads may be symmetrical.
Preferably, the entire surfaces of thebeads2151, or at leastouter beads2151aand2151b, may be smooth or at least substantially smooth. Or, at least all surfaces that may be expected to contact tissue during a surgical procedure may be substantially smooth. For example, providing a smooth front end and a smooth trailing end may allow the lysing tip to be moved in a forward direction and then in a rearward direction back and forth without catching an undesirable amount of tissue on beads to inhibit such movement. As shown, in some embodiments, the trailing end of some beads, such asbeads2151aand2151b, may comprise a flat surface such that each bead comprises a frusto shape or another similar shape. Preferably, at least the forward or distal surface of each bead is substantially smooth and defines an ellipsoidal shape or another shape having a substantially smooth forward surface. In the depicted embodiment, beads surfaces may havefacets2152.
In other contemplated embodiments, providing a rough trailing end may create frictional drag on that portion of the bead thus helping reorient the front end of the bead for further tissue passage. Thus, in some embodiments, the trailing end may have a rougher surface than the front end
As previously mentioned, in some embodiments, it may be desirable to allowbeads2151 to rotate, at least partially, on lysingmember2160. Thus,beads2151 may not be fixed three-dimensionally with respect to lysingmember2160 and/or one or more other elements of lysingtip2110. In some such embodiments,beads2151 may be at least partially rotatable with respect to the remainder of lysingtip2110. In embodiments in whichbeads2151 are rotatable in this manner, it may be desirable to use a lysing member having a circular cross section.
Preferably, lysingmember2160 terminates withinouter beads2151aand2151b. Thus, it may be desirable to melt, tip, ball, crimp, fold, tie, or otherwise couple the ends of lysingmember2160 withinouter beads2151aand2151bat opposing lysingmember coupling tips2163aand2163b. Preferably, lysingtip2110 is configured such that each ofbeads2151 is rotatable independent of one another.
Coupling tip2163a/bmay be configured to engage a ledge positioned at a transition point between two concentric tunnels (2159a/2159b) (similar to that depicted inFIG.17cattunnels1759a/1759b). More particularly,outer tunnel2159bmay comprise a larger diameter or other cross-sectional dimension thaninner tunnel2159asuch that lysingmember2160 may extend throughinner tunnel2159abutcoupling tip2163adue to its larger size may be configured to extend throughouter tunnel2159bwithout passing throughinner tunnel2159a. In other embodiments, there may be a single tunnel that tapers (similar totunnel1759cinFIG.17c) from a larger dimension on the outer side ofbead2151 to a smaller dimension toward the inside of the bead relative to thelysing tip2110.
In some embodiments, at least a portion of graspingplate2161 may comprise a conductive material and may be configured to receive electrosurgical energy, such as from a grasping/control instrument2190 or another surgical tool or external wire, and deliver such energy to lysingmember2160. For example, in some such embodiments, electrosurgical energy may be delivered through graspingjaws2193a/2193b, into graspingplate2161 and into lysingmember2160. In other embodiments, graspingplate2161 may be insulated and electrosurgical energy may instead be delivered to lysingtip2110 in another manner. For example,upper jaw2193amay be insulated but comprise one or morenon-insulated projections2196aand2196bthat may correspond to one or morenon-insulated openings2173aand2173brespectively in grasping plate2161 (that is otherwise substantially insulated). Although a single projection/opening may be used in some embodiments, it may be preferable to have two such projections/openings as depicted inFIGS.21band21c. Providing two or more projections/openings may improve stability of the lysing tip during treatment. One or both of the projections/openings may be configured to deliver electrosurgical energy frominstrument2190 to lysingtip2110. This configuration with multiple projection/opening pairs may be used in similar embodiments disclosed herein.
In embodiments comprising a free-floating lysing tip, including the embodiments ofFIGS.17-31 and35-38, certain preferred embodiments may have a size/length TL (as illustrated inFIGS.10d/10e) of about 15 mm from the end of one protrusion and/or bead to the opposite protrusion/bead on the opposite end; the height BH (as illustrated inFIGS.10d/10e) of the largest outer beads may range from 2 mm to 10 mm. In some embodiments, this dimension may be defined by the distance from the upper end of one or more (in some embodiments, each) beads to the lower end of one or more beads. In some free-floating embodiments, the lysing tip may have a size/width TW (as illustrated inFIGS.10d/10e) of about 4.5 mm from the distal end of the beads to the proximal end of the lysing tip. However, it should be understood that a wide variety of alternative shapes and/or sizes may be usable depending upon the particular surgical procedure involved.
FIGS.22a-eillustratesystem2200 comprises lysingtip2210 and grasping/delivery instrument2290, this embodiment only differing fromsystem2100 in thatbeads2251a/2251bare rounded on the outerproximal corners2253a/2253brelative to the axis of the grasping/control instrument2290. Rounding the outer proximal corners may further inhibit lysingtip2210 from catching tissue rather than cutting or bluntly separating said tissue.Lysing tip2210 comprises graspingplate2261, lysingrod2260, and2beads2251a/2251bthrough which lysingrod2260 extends (through tunnels inbeads2251 similar to tunnels throughbeads2151a/2151binFIG.21a-21e). Each ofbeads2251 may be coupled to lysingrod2260 by couplingtips2263a/2263band as otherwise set forth herein. Upper andlower jaws2293a/2293b(that, when closed, define receiving slot2297) respectively may grasp graspingplate2261.Lysing tip2210 is configured to be completely separable from the grasping/control instrument2290 of the system.Lysing tip2210 may comprise a plurality of protrusions2201 comprisingbeads2251a/2251bandrecessions2202 between the bead pairs.
FIGS.23a-dillustratesystem2300 comprising lysingtip2310 and grasping/control instrument2390, this embodiment only differing fromsystems2100 and2200 in thatbeads2351 have an ellipsoidal shape along the entire length of the beads and compriseholes2355 which may be configured for receipt of a cord that may be a suture, hook, or similar device that may grasp and hold lysingtip2301. This may be used as a safety feature for ensuring that a surgeon has the ability to retrieve lysingtip2301 in the event that it becomes uncoupled frominstrument2390. This additional length as compared to the shapes of the beads in embodiments inFIGS.21a-eand22a-emay assist in maintaining the optimal positioning forbeads2351 to migrate through and/or separate and/or cut tissue.Lysing tip2310 comprises graspingplate2361, lysingrod2360, and2beads2351 through which lysingrod2360 extends (through tunnels inbeads2351 similar to tunnels throughbeads2151a/2151binFIG.21a-21e). Each ofbeads2351 may be coupled to lysingrod2360 by couplingtips2363 and as otherwise set forth herein. Upper andlower jaws2393a/2393brespectively may grasp graspingplate2361.Lysing tip2310 is configured to be completely separable from the grasping/control instrument2390 of the system.Lysing tip2310 may comprise a plurality ofprotrusions2301 comprisingbeads2351 andrecessions2302 between the bead pair.
Given the extra length of thebeads2351 in this embodiment, material is available forholes2355. Hole(s)2355 may, together with acord2344, for example, comprise an example of means for detachably maintaining retrievability of a lysing tip. In preferred embodiments and/or implementations,suture2344 or another loopable element may be looped through one or more such hole(s) and then may extend through one or more cannulas used to deliver lysingtip2310 proximally back to a surgeon. In this manner, in the event of a failure to grasp or otherwise couple lysingtip2310 to a grasping/control instrument, such as grasping/control instrument2390, lysingtip2310 may be retrieved from within a patient's body by pulling onsuture2344 to retract lysingtip2310 though a cannula. In some embodiments,hole2355 may also or alternatively be used to maintain position of lysingtip2310 while awaiting delivery of a grasping/control instrument2390 for performing surgical procedures. Upon properly coupling lysingtip2310 with an appropriate tool for grasping and/or controllinglysing tip2310, such as grasping/control instrument2390, a surgeon may cutsuture2344, preferably near a knot or other feature used to form a loop aroundhole2355. If asuture2344 or other similar material/element is used that is sufficiently flexible and non-disruptive, this shorter loop may be configured to be present during a surgical procedure usinglysing tip2310 without unduly interfering with the procedure. In alternative embodiments,holes2355 may be available as a platform/location to add other features/components such as providing a location for a placement of one or more sensors and/or RFID location component(s) and/or being used for placement of luminescent and/or light production element(s) for visualization, for example, tritium and the like.
In alternative embodiments,hole2355 may be moved to fully or partially intersecttunnel2354 thus allowing communication with lysingrod2360; thus a weld, plug, glue, insert or other method of fixation may be inserted viahole2355 to attach to lysingrod2360 thus restricting lateral movement of a bead. To reduce escape of electrosurgical energy throughhole2355, an insulator comprised of epoxy, plastic, ceramic or the like may be placed in part or all of the remaininghole2355. This alternative embodiment may be applied to other embodiments herein.
Another embodiment is depicted inFIGS.24aand24b.System2400 comprisesmodular lysing tip2410 comprisingrecessions2402 created byadjacent protrusions2401.Lysing tip2410 further comprises asupport member2470 defining abow shape2470 that may be coupled physically and electrically to ashaft2499aextending proximally frombow2470.Shaft2499amay be conductive and/or may reversibly couple withconductive slot2479sformed in anelectrosurgical instrument2479 which may be an electrosurgical pencil (such as a ‘Bovie’ and/or other electrosurgical pencil and/or other electrosurgical adaptive device(s)) capable of receivingshaft2499a, through which electrosurgical energy may be directed and controlled to lysingtip2410. Lead2479L may be coupled with an electrosurgical generator.Beads2451a/2451b/2451c/2451dmay comprisefacets2452 and may be coupled tosupport member2470 by lysing rod (not shown inFIGS.24a/24b) which is covered byspacers2462a/2462b/2462c. Couplingtips2463, as stated earlier herein, couple the lysing rod in place withinouter beads2451a/2451d.Insulation2499bmay cover or substantially covershaft2499ato facilitate handling by personnel and may be extended to cover all or portions ofbow2470 preventing electrosurgical energy from being distributed to tissue from thebow2470. This embodiment may have uses in open surgeries and/or non-CDTD procedures.
An alternative embodiment is depicted inFIG.24c.System2400′ comprisesmodular lysing tip2410′ (which is comprised ofouter beads2451a′/2451d′, and lysingrod2460′),shaft2499a′ andinsulated covering2499b′ that terminates distally with bulbous projection/protrusion2499t. One or more of the exposed segments of lysingrod2460′ may be covered byspacers2462′.Lysing rod2460′ may be electrically coupled to ashaft2499a′ extending proximally from lysingrod2460′.Shaft2499a′ may be conductive and/or may reversibly couple with anelectrosurgical instrument2479 which may be an electrosurgical pencil (such as a ‘Bovie’ and/or other electrosurgical pencil and/or other electrosurgical adaptive device(s)) capable of receivingshaft2499a′ within aconductive slot2479sthrough which electrosurgical energy may be directed and controlled to lysingtip2410′. Insulated covering2499b′ may cover or substantially covershaft2499a′ to facilitate handling by personnel and may be extended distally in the shape of or to substantially mimic the shape of the distal portion of abead2451a′/2451d′, thus serving as a 3rdprojection/bead. More particularly, thisbulbous protrusion2499tmay extend distally as far as the tips ofbeads2451a′/2451d′. This embodiment may have uses in open surgeries and/or non-CDTD procedures.
The CDTD and/or non-CDTD systems and/or apparatus (hereafter “TD”) disclosed herein may be used to treat the following disclosed below.
In a general implementation of a method using one or more of the devices described herein, a tip deployment pocket may be created at or near the entrance incision, for example, in skin or muscle. Alternatively, some implementations may not require a tip deployment pocket. The lysing tip of the TD may be inserted through the entrance incision and in some implementations into the tip deployment pocket while in other implementations directly into a body cavity. The lysing tip may then be reconfigured from a delivery configuration to a treatment configuration such as by rotating the lysing tip and/or coupling the lysing tip to a grasping/control instrument. The lysing tip may then be activated. A dissection path may then be made to one or more target tissues. The lysing tip may then be used to dissect around or through target tissues and/or used to treat the target tissue. In some implementations, the one or more target tissues and/or surrounding tissues may then be treated to achieve hemostasis with the lysing tip or the tissue modification tip (TMT). The lysing tip may then be rotated back to a delivery configuration to allow the lysing tip to be withdrawn. In some implementations, the lysing tip may delivered and/or withdrawn using one or more cannulas. In other implementations, the lysing tip may delivered and/or withdrawn without a cannula.
InFIGS.25a-e, system2500 atether2544 extends through anopening2593hformed in ajaw2593 of the grasping/control instrument2591.Tether2544 may further be configured to be coupled with free-floatinglysing tip2510 that may be comprised of support member/bow2570, graspingpad2571 located on support member/bow2570,beads2551,spacers2561, and rod (not shown). In the depicted embodiment,tether2544 couples with graspingpad2571. More particularly, graspingpad2571 comprises anopening2571hconfigured to receive thetether2544 as shown in the cross-sectional view ofFIG.25d. In some embodiments, theopening2571hmay comprise a blind opening in whichcase tether2544 may comprise adistal bulb2544cand/or stop that preventstether2544 from pulling through theopening2571h. Alternatively, opening2571hmay comprise a through-hole which may allowtether2544 to extend all the way throughopening2571hon both ends of the opening.
In the depicted embodiment, by pulling ontether2544 either manually or by way of a mechanism,tip2510 may be configured to be directed into thejaws2593/2594 of grasping/control instrument2591. In still other embodiments,tether2544 may be coupled withtip2510 without also extending through one or both ofjaws2593/2594. In this manner thetip2510 may be retrieved simply by pulling on thetether2544. In other embodiments, atether2544 may extend through other portions of the grasping instrument, such as thebottom jaw2594 and/or bothjaws2593/2594 and/or through the center of the grasping/control instrument2591.
In some embodiments, one or more magnets may be used to guide lysingtip2510 towards and/orlock lysing tip2510 in a desired location such as withinjaws2593/2594 of the graspingcontrol instrument2591. For example, one or more magnets may be positioned along grasping pad2571 (magnet2592p) and/or within one or both ofjaws2593/2594 (magnet2592j) ofsystem2500. If a magnet is positioned within one or bothjaws2593/2594, graspingpad2571 may comprise a magnetic portion and/or element configured to engage such magnet(s). Similarly, if a magnet is positioned on graspingpad2571, a magnetic portion and/or element may be positioned within one or both jaws. Alternatively, magnets may be positioned on both the grasping pad and one or both of the jaws.
The tether may be packaged with a tether already attached or medical personnel at the procedure may choose an appropriate tether to thread and catch in the lysing tip and thread through the jaw with the through-hole.
The surgeon may attach the cord/suture to hole2571 leaving a tail of stitch that may be up to 50 cm long. The graspinginstrument2591 containinghole2593hmay be inserted into the body percutaneously and exit through an larger trocar for example located in the umbilicus. The tail of the suture/cord may then be pulled back out the original percutaneous incision and fed throughhole2593h. The graspinginstrument containing hole2593hmay then be reinserted percutaneously and thelysing tip2510 fed down the second (for example, umbilical trocar) percutaneous body cavity entry/wound. The cord/suture tail is then pulled by the surgeon to seat the frame within the grasper.
Yet another embodiment of alysing tip2610 comprisingbeads2651a/2651b/2651c/2651dis depicted inFIGS.26aand26b.Lysing tip2610 comprises asupport member2670 which may be in the approximate shape of a bow as previously discussed. However, the distal end of lysingtip2610 is bowed in the opposite direction such thatmiddle beads2651b/2651cprotrude distally to a greater degree thanouter beads2651a/2651d. In addition, lysingrod2660 rather than being straight as in previous embodiments collectively curves and/or bows distally. In some embodiments, however, each of thevarious segments2662a/2662b/2662cbetween adjacent beads may be straight or be substantially straight. As also previously discussed,support member2670 may comprise anopening2673 which may be configured to receive a tooth or other projection of a grasping/control instrument (not shown in this figure, but depicted in other embodiments). InFIG.26a,support member2670 may further comprise atongue2676 that protrudes distally to couple with the center segment of lysingrod2660. More particularly, in the depicted embodiment,tongue2676 comprises a groove defined on either side byedges2676′ configured to receive center segment of lysingrod2660 so as to deliver electrosurgical energy from an instrument into lysingrod2660. As previously discussed, each of the various segments of lysingrod2660 is preferably electrically coupled through adjacent beads to its adjacent lysing member. As shown inFIG.26a, spacers may be provided between outer beads and but not the adjacent middle beads. This may be becausetongue2676a/2676a′ may serve as a suitable spacer. However, as shown inFIG.26b, in some embodiments,center spacer2662bmay be provided on the center segment of lysingrod2660 if needed or desired.
FIGS.27-30 comprise various embodiments of free-floating lysing tips that may be used with the various surgical tools set forth, for example, inFIGS.17a-m. However, alternative embodiments are contemplated in which these free-floating lysing tips may instead be modified so as to be coupleable with actuation rods and/or one or more cannulas as set forth herein such that the free-floating lysing tips become non-free-floating lysing tips. as shown, for example, inFIGS.14a-n.
InFIGS.27a-j, lysingtip2710 is “free-floating” (can be uncoupled from any control instrument or cannula) and comprises a plurality ofsleeves2780/2781 positioned on lysingrod2760 which may correspond in number to the number ofbeads2751a/b/c/d.Beads2751a/b/c/dmay be molded onto or otherwise positioned onto one or more sleeve configurations, for example, outerbead sleeve configuration2780a/2780band middle bead sleeve configuration2781a/2781b. Preferablysleeves2780/2781 are made of a material configured to insulate the material making up the beads from the heat generated by the lysingrod2760 during a surgical procedure.Sleeves2780/2781 may also or alternatively serve as hubs permitting rotation of beads around the axis of lysingrod2760. For example, the beads may rotate about the rod upon encountering tissue similar to that of a vegetable/fruit peeler.
Middle bead sleeve2781 may comprise a raisedband2784 which is formed at a central or substantially central location around both middle-bead sleeves2781a/2781bwhich may serve to prevent lateral movement ofmiddle beads2751band/or2751coff of middle-bead sleeves2781a/2781b.Bead band channel2753 may be configured to accept raisedband2784. Likewise,outer bead sleeves2780a/2780bcomprise anexternal ledge2786aandinternal ledge2786bthat transitions between alarger diameter portion2782 and asmaller diameter portion2783 of an inner tunnel of the outer bead sleeves. Thelarger diameter portion2782 is alternatively referred to herein as a raised band. In some preferred embodiments comprising bead sleeves, the beads may comprise a molded or moldable material, such as a moldable, biocompatible plastic, gelatin (for example, protein, polysaccharides and/or derivatives thereof), or hydrogel, for example. In some such embodiments, the beads may be overmolded onto each of their respective sleeves.
External sleeve ledge2786amay be configured to engage a correspondinginternal bead ledge2759 within outer beads2750a/2750b. Similarly,outer bead sleeves2780a/2780bmay comprise two concentric holes withledge2786bapproximately half-way between the opposite openings.Internal bead ledge2786bmay be configured to engagecoupling tips2763. This configuration creates a feature that may prevent lateral movement ofouter beads2751a/2751doff of outer bead sleeves2781a/2781b. In other embodiments,coupling tip2763 may engage a single tunnel that tapers (similar totunnel1759cinFIG.17c) from a larger dimension on the outer side of bead to a smaller dimension toward the inside of the bead as depicted inFIG.27j. In some embodiments, it may be desirable to provide features and/or elements that inhibit or limit the ability of the electrosurgical energy to discharge from the opposing ends of the lysingrod2760 atcoupling tips2763. Thus, in some such embodiments,coupling tips2763 may be coated or covered with a suitable insulating material such as an epoxy with non-conductive properties. Alternatively,outer bead hole2754 at the end with the larger-opening may be capped or plugged with an element configured to be received or otherwise engage the larger opening of the bead. Preferably, this element will have non-conductive properties similar to the insulating material previously referenced.
As depicted inFIG.27c, lysingtip2710 may compriseprotuberances2765c/2765dpositioned on/coupled to lysingrod2760, oneprotuberance2765c/dmay be positioned on each side of eachmiddle bead2751cas shown inFIG.27c.Protuberances2765c/dmay serve to prevent or limit lateral movement ofmiddle beads2751b/2751con the lysingrod2760 and/or may, depending upon a protuberance pair's distance from a bead, serve to limit or prevent rotation of beads around the axis of lysingrod2760. In alternative embodiments, one or more spacers2762 (and such as those inFIGS.9a-9e, spacers962) may be used in place ofprotuberances2765c/d. In the depicted embodiment,spacer2762 inFIG.27cis pentagonal in cross-section; in other embodiments, alternative spacers with unique cross-sectional configurations, such as for example those set forth inFIGS.12h-t, may be used. In alternative embodiments, lysingrod2760 may be deformed prior to coupling with a middle bead sleeve such that the outer diameter of2760 may couple via friction fit with the inner tunnel surface ofmiddle bead sleeve2781.FIGS.27band27cpurposefully have components removed to expose inner components and also illustrate different means to hold middle beads in an intended position via protuberances and/or spacers. Alternatively,middle bead sleeves2781 may be more loosely coupled with lysingrod2760 so as to allow for rotation ofmiddle bead sleeve2781 thereon, and thereby allow for at least some rotation of their corresponding beads on lysingrod2760. In alternative embodiments, lysingtip2710 may be configured without a solid lysing rod and/or without spacers and/or welds and the like. In such embodiments,internal bead tunnels2754 and support member holes2767a/2767bmay be configured to accommodate a hollow lysing rod similar to that depicted inFIG.17k. Between beads, the hollow lysing rod may be deformed in a manner to prevent lateral movement of beads and/or prevent rotation of beads. The hollow lysing rod may be deformed minimally or to a point that it is substantially flat. In such embodiments, it may be preferable for the front edge to point distally as the leading front edge. In such embodiments, screws may secure one or both ends of the hollow lysing rod withinouter beads2751a/2751d. The configurations of this alternative embodiment may be available for any other similar embodiment contemplated herein.
In this configuration,adjacent protrusions2701 createrecessions2702 in which recessed lysingrod2760 may deliver electrosurgical energy during a surgical procedure.
FIG.27eillustrates a perspective view ofouter bead2751acoupled toouter bead sleeve2780awithcoupling tip2763 being recessed withinouter bead sleeve2780a.Lysing rod2760 is illustrated inFIG.27dbeing received withinouter bead sleeve2780a.FIG.27dillustrates how lysing rod, sleeve and bead may be assembled:Outer bead sleeve2780amay be extended intoouter bead2751astopping at the point thatexternal sleeve ledge2786areaches theinternal bead ledge2759 which may be followed by extension of lysingrod2760 throughouter bead sleeve2780astopping at thepoint coupling tip2763 reaches theinternal sleeve ledge2786bcreated by the larger-diameterbead sleeve hole2786hand smaller-diameter sleeve hole2787a. In alternative embodiments, as depicted inFIG.27j, thesleeve2780′ may be configured to have a single cone-shapedtunnel2786′ that tapers (similar totunnel1759cinFIG.17c) from a larger dimension on the outer side of bead to a smaller dimension toward the inside of the bead in order to engagecoupling tip2763.
Outer beads2751a/dmay comprisehole2755 through which a cord may be hooked and/or tied in order to facilitate deployment or retrieval as earlier stated herein regardinghole1755 inFIG.17d.
Support member2770 may be preferably insulated, except for regions on which it is desired to transfer electrosurgical energy such as (1) at one or more surfaces of graspingpad2771, (2) within the 2 distal support member holes (as shown inFIG.17e,1767a/1767b), and/or (3) the opposing distal ends ofsupport member2770, in some cases distal of lysingrod2760 in order to deliver electrosurgical energy not only through lysingrod2760 but also through these distal ends ofsupport member2770.
Support member2770 in the current embodiment comprises a bow shape comprising two opposing end tips comprising holes or other openings through which lysingrod2760 extends. The two tips ofsupport member2770 may extend far enough distally to provide sufficient material to form the lysing rod through-holes. Alternatively, openings comprising slots or the like may be formed at one or both of the two opposing tips ofsupport member2770 if desired.
The two tips ofsupport member2770 preferably do not extend beyond the distal tip of any bead and preferably remain as proximal to lysingrod2760 as possible. The ends/tips ofsupport member2770 may or may not be electrically insulated. If insulated, said tips will act more likebeads2751a/b/c/dto physically separate tissues or tissue planes; however, if not insulated, said tips may perform like lysingrod2760 delivering electrosurgical energy to lyse tissue.
FIGS.27h-iillustratesmiddle bead2751bcomprised of facets2752 (2 of a total of 4 on this bead are identified in the illustration), coupled tomiddle bead sleeve2781 through which lysingrod2760 extends.Middle bead2751bmay differ from outer bead in that its length may be shorter and itsrear wall2758 may be flat or substantially flat. The length ofmiddle bead2751bmay be such that the rear portion ofmiddle bead2751b/cmay not contactsupport member2770 in its relaxed state and/or when the bead's distal tip is pointing in the same direction as lysingtip2710, however,middle bead2751bmay contactsupport member2770 if lysingrod2760 is pushed back or otherwise deformed during a surgical procedure and/or themiddle bead2751b/cis rotated about the lysingrod2760 such that the top or bottom of the rear portion of the bead may contactsupport member2770. For example, the spacing betweenmiddle beads2751b/candsupport member2770 may be used to selectively limit the amount with whichmiddle beads2751b/cmay rotate. Similarly, in some embodiments, this spacing may be configured to serve as a backstop to allow for a predetermined amount of proximal movement ofmiddle beads2751b/cduring a procedure.
InFIGS.28a-L,outer beads2851a/2851ddefine an annular shape. to More particularly,outer beads2851a/2851dcompriseannular bead structure2857. In addition, these beads may be elongated or oval in cross section.Middle beads2851b/2851con the other hand have similar defined protrusions on their distal ends, however, proximal ends of these beads terminate in opposingknobs2855 rather than defining a full annular shape. In both middle and outer beads, abead hub2856 is positioned withinannular bead structure2857 to allow for coupling ofbeads2851 with their corresponding sleeves.Bead hub2856 is coupled toannular bead structure2857 by way of one ormore spokes2858 and/or abead hub frame2856a. In the depicted embodiment,bead hub frame2856aextends about a central portion ofbead hub2856 frombead hub2856 toannular bead structure2857.Bead hub frame2856ais only coupled to a portion of annular bead structure, and a portion ofbead hub2856. However, alternative configurations are possible in whichbead hub frame2856amay be coupled to the entireannular bead structure2857 and/or the full periphery ofbead hub frame2856a. Asingle spoke2858 may extends frombead hub2856 in a direction perpendicular tobead hub frame2856a. As best depicted inFIG.28k, spoke2858 protrudes laterally (towards opposite lateral ends of the lysing tip) in both directions beyond a profile of theannular bead structure2857. However,bead hub frame2856adoes not protrude laterally in this manner.Spoke2858 also extends frombead hub frame2856a. However, other embodiments are contemplated in which additional spokes may be used, in some such embodiments in place of abead hub frame2856a, as discussed below. Such annular shapes may be beneficial components may be less costly to produce, they may withstand heat generated from the interaction of electrosurgical energy with tissue, and they may provide more benefits for dissecting the more delicate tissues such as those found in the abdomen including tissues attached to bowel and mesentery.
In this configuration,adjacent protrusions2801 createrecessions2802 in which recessed lysingrod2860 may deliver electrosurgical energy during a surgical procedure.
FIG.28dis a side view of lysing tip2810 comprisingsupport member2870,coupling tip2863,spokes2858a/2858b/2858ccoupling bead hub2856 with beadannular structure2857.
FIGS.28eand28fillustrate perspective and side views ofouter beads2851 coupled toouter bead sleeve2880 through which lysingrod2860 extends.Bead hub2856 may be formed onouter bead sleeve2880, said hub coupling to inner surface ofannular structure2857 viaspokes2858a/2858b/2858c.
Outer bead sleeves2880a/2880bmay comprise an internal and/or an external ledge that transition between a larger diameter portion and a smaller diameter portion of the outer bead sleeves. For example, outer bead sleeve may comprise anexternal sleeve ledge2886aand internal sleeve ledge (as illustrated inFIGS.27a-j,internal sleeve ledge2786b).External sleeve ledge2886amay be configured to engage a corresponding internal bead ledge (as illustrated inFIGS.27a-j, internal bead ledge2759). within outer beads2850a/2850b. More particularly,outer bead sleeves2880a/2880bmay comprise two concentric holes with an internal bead ledge approximately half-way between the opposite openings. The internal bead ledge may be configured to engagecoupling tips2863. This configuration creates a feature that may prevent lateral movement ofouter beads2851a/2851doff of outer bead sleeves2881a/2881b.
FIG.28hillustrates how lysing rod, sleeve and bead may be assembled:Outer bead sleeve2880amay be extended intoouter bead2851astopping at the point thatexternal sleeve ledge2886areaches the internal bead ledge which may be followed by extension of lysingrod2860 throughouter bead sleeve2880astopping at thepoint coupling tip2863 reaches the internal sleeve ledge created by the larger-diameter inner sleeve hole and smaller-diameter sleeve hole (as illustrated inFIGS.27a-jatinternal sleeve hole2786aandexternal sleeve hole2786b).
As depicted inFIGS.28a-L, lysingrod2860 may be deformed prior to coupling with bead sleeves in the areas to be coupled with the sleeves such that the outer diameter of lysingrod2860 may couple via friction fit with the inner tunnel surface ofmiddle bead sleeve2881. For example, these regions may be flattened slightly or otherwise made into a slightly elongated or oval shape so as to improve the ability of the sleeves to engage the lysing rod in these regions via friction fit. In alternative embodiments, lysing tip2810 may comprise protuberances positioned on/coupled to lysingrod2860, one protuberance, for example, may be positioned on each side of eachmiddle bead2851c. Protuberances may serve to prevent or limit lateral movement ofmiddle beads2851b/2851con the lysingrod2860 and/or may, depending upon a protuberance pair's distance from a bead, serve to limit or prevent rotation of beads around the axis of lysingrod2860. In alternative embodiments, one or more spacers (and such as those inFIGS.11a-f,spacers1162a/b/c) may be used in place of protuberances2865. Alternatively,middle bead sleeves2881 may be more loosely coupled with lysingrod2860 so as to allow for rotation ofmiddle bead sleeve2881 thereon, and thereby allow for at least some rotation of their corresponding beads on lysingrod2860.
In alternative embodiments, the sleeve may be configured to have a single cone-shaped tunnel that tapers and may engage coupling tip (similar totunnel2786′ inFIG.27j) from a larger dimension on the outer side of bead to a smaller dimension toward the inside of the bead. In alternative embodiments, lysing tip2810 may be configured without a solid lysing rod and/or without spacers and/or welds and the like similar to that depicted inFIG.17k. Between beads, the hollow lysing rod may be deformed in a manner to prevent lateral movement of beads and/or prevent rotation of beads. The hollow lysing rod may be deformed minimally or to a point that it is substantially flat. In such embodiments, it may be preferable for the front edge to point distally as the leading front edge. In such embodiments, screws may secure one or both ends of the hollow lysing rod withinouter beads2851a/2851d. The configurations of this alternative embodiment may be available for any other similar embodiment contemplated herein.
FIGS.28i-L illustratemiddle bead2851b/2851ccoupled tomiddle bead sleeve2881 through which lysingrod2860 extends and from which middle band2984 protrudes.Middle bead2851bmay differ fromouter bead2851ain that its length is truncated proximal tobead hub2856 terminating inknobs2855.Knobs2855 may inhibit the lysing tip2810 from catching tissue rather than cutting or separating it and/or may limit rotation ofmiddle bead2851 around lysingrod2860. The length ofmiddle bead2851bmay be such thatknobs2855 and proximal portions ofbead hub2856 may not contactsupport member2870 in its relaxed state and/or when the bead's proximal tip is pointing in the same direction as lysing tip2810. However, in this embodiment,middle bead knobs2855 may contactsupport member2870 if lysingrod2860 is deformed during a surgical procedure and themiddle bead2851 is rotated about the lysingrod2860 such that the top or bottom of the rear portion of the bead may contactsupport member2870. The spacing betweenmiddle beads2851 andsupport member2870 may be used to selectively limit the amount with whichmiddle beads2851 may rotate. In this embodiment,support member2870 may not serve as a backstop to permit a predetermined amount of proximal movement ofmiddle beads2851a/2851bduring a procedure. Middle bead sleeve may comprise raisedband2884 to engage the bead to limit lateral movement.
FIGS.29a-fdiffers from that of28a-L in thatmiddle beads2951b/2951cinstead of terminating at knobs (knobs2855 inFIGS.28a-L) define an annular shape having a flattened or slightly arcedrear end2955 and outer beads comprise less bead hub frame material by directly attaching the proximal portion of the distal tip to the bead hub2256.
Adjacent protrusions2901 createrecessions2902 in which recessed lysingrod2960 may deliver electrosurgical energy during a surgical procedure.
FIG.29cis a side view of lysing tip2910 comprisingsupport member2970,coupling tip2963, spoke2958awithdirect connection points2958g/2958hcoupling bead hub2956 withouter bead2951a/2951dannular structure2957.
In both middle and outer beads, abead hub2956 couples with its corresponding sleeve. In middle beads, one ormore spokes2958a/2958b/2958cmay extend frombead hub2956 to theannular structure2957 as support andbead hub frame2956aby itself or in conjunction with spokes may couple the annular structure tobead hub2956. As illustrated inFIG.29c, outer beads2951 comprisebead hub2956 coupled toannular structure2957 by spoke2958aat the distal portion of the bead and direct coupling ofbead hub2956 to the material comprising internal portion ofannular structure2957 atdirect connection points2958gand2958h.
FIGS.29eand29fillustrate perspective views of outer bead2951 coupled toouter bead sleeve2980 through which lysingrod2960 extends.Bead hub2956 may be formed onouter bead sleeve2980.
Outer bead sleeves2980 comprise a ledge2986 that transitions between a larger diameter portion and a smaller diameter portion of the outer bead sleeves. Sleeve ledge2986 may comprise anexternal sleeve ledge2986aand an internal sleeve ledge (as illustrated inFIGS.27a-j,internal sleeve ledge2786b).External sleeve ledge2986amay be configured to engage a corresponding internal bead ledge (as may be illustrated inFIGS.27a-j, internal bead ledge2159). within outer beads2950a/2950b. Similarly,outer bead sleeves2980 may comprise two concentric holes with internal bead ledge approximately half-way between the opposite openings. Internal bead ledge may be configured to engagecoupling tips2963. This configuration creates a feature that may prevent lateral movement ofouter beads2951a/2951doff ofouter bead sleeves2980.
In alternative embodiments, the sleeve may be configured to have a single cone-shaped tunnel that tapers and may engage coupling tip (similar totunnel2786′ inFIG.27j) from a larger dimension on the outer side of bead to a smaller dimension toward the inside of the bead.
As depicted inFIGS.29a-f, lysingrod2960 may be deformed prior to coupling with a middle bead sleeve such that the outer diameter of lysingrod2960 may couple via friction fit with the inner tunnel surface ofmiddle bead sleeve2981. In alternative embodiments, lysing tip2910 may comprise protuberances positioned on/coupled to lysingrod2960, one protuberance, for example, may be positioned on each side of eachmiddle bead2951c. Protuberances may serve to prevent or limit lateral movement ofmiddle beads2951b/2951con the lysingrod2960 and/or may, depending upon a protuberance pair's distance from a bead, serve to limit or prevent rotation of beads around the axis of lysingrod2960. In alternative embodiments, one or more spacers (and such as those inFIGS.9a-9e, spacers962) may be used in place of protuberances2965 which may be positioned at any angle on the cross section of the lysing rod, in this depiction facing proximally2965c/dand distally2965a/b. Alternatively,middle bead sleeves2981 may be more loosely coupled with lysingrod2960 so as to allow for rotation ofmiddle bead sleeve2981 thereon, and thereby allow for at least some rotation of their corresponding beads on lysingrod2960. In alternative embodiments, lysing tip2910 may be configured without a solid lysing rod and/or without spacers and/or welds and the like similar to that depicted inFIG.17k. Between beads, the hollow lysing rod may be deformed in a manner to prevent lateral movement of beads and/or prevent rotation of beads. The hollow lysing rod may be deformed minimally or to a point that it is substantially flat. In such embodiments, it may be preferable for the front edge to point distally as the leading front edge. In such embodiments, screws may secure one or both ends of the hollow lysing rod withinouter beads2951a/2951d. The configurations of this alternative embodiment may be available for any other similar embodiment contemplated herein.
FIG.29fillustrates how lysing rod, sleeve and bead may be assembled:Outer bead sleeve2980 may be extended intoouter bead2951astopping at the point thatexternal sleeve ledge2986areaches the internal bead ledge which may be followed by extension of lysingrod2960 throughouter bead sleeve2980 stopping at thepoint coupling tip2963 reaches theinternal sleeve ledge2986bcreated by the larger-diameter inner sleeve hole and smaller-diameter sleeve hole (as illustrated atinternal sleeve hole2787aandexternal sleeve hole2786hinFIGS.27a-j).
InFIGS.30a-k, the beads again define an annular shape, however, these beads may be configured to be wider, unlike beads previously discussed which define in cross section an oval or circular shape, thus the beads in this embodiment may define a more cross-sectionally elongated shape and may be configured to have opposing upper and lower surfaces defining the annular structure that are parallel or at least substantially parallel in cross-section. These beads may be referred to as annular bands and may be flexible by way of material or a combination of material and/or thicknesses and/or configuration such that they can be compressed in some embodiments either from the top and bottom or from the opposing distal ends. In some embodiments, beads may be resiliently flexible such that they naturally return to their original state after being compressed. Various embodiments may enable greater compressibility, for example, by removing and/or angling a bead spoke between the bead hub and theannular structures3057 ofbeads3051a/b/c/d.
This ability to compress and be restored may be useful to allow the lysing tip3010 to self-adjust during certain surgical procedures, in particular those involving the intermixing of delicate tissues with dense/fibrous tissues (such as pre-existing scar), for example, in the abdomen attached to the bowel and/or mesentery. To illustrate with more particularity, upon being compressed from the top or bottom, the distal tip may be deformed to form a more acute angle of attack facilitating tissue separation and the cross sectional profile along the height of the tip may be reduced. Similarly upon encountering more dense and/or more fibrous tissue at the distal tip, the tip may slow or cease movement, however, the force from the surgeon's motion will continue to push the lysing segment closer to the more dense and/or more fibrous target tissue effectively providing more enhanced power to lyse the tissue rather than requiring an increase of the power from the electrosurgical generator. In some embodiments, this may also reduce the need for increasing power from the electrosurgical generator in order to lyse and/or separate such tissues. This may also enhance safety because it may be safer for patient safety to operate electrosurgical generators at the minimum necessary power.FIGS.30aand30billustrate perspective and upper views respectively ofprotrusions3001,recessions3002,beads3051a/3051b/3051c/3051d, lysingrod3060, andsupport member3070 partially comprisinggrasping pad3071.FIG.30cis a side view of lysing tip3010 illustrating the side andmiddle beads3051a/b/c/dandsupport member3070.FIG.30dillustrates amiddle bead3051bor3051cwithbead hub3056 andspokes3058a/3058b; other than the shape of the bead, its structure in coupling to the lysing rod3060 (middle andouter sleeves3080 and3081 respectively) is similar toouter beads3051a/2451band similar to the embodiments inFIGS.27-29 viacoupling tip3063.FIGS.30e-30killustrate perspective, side elevation, and top plan views of an outer bead in relaxed and compressed states.FIGS.30e/30h/30jillustratebead3051a/3051din the relaxed and/or “as manufactured” state from perspective, side, and upper views.FIGS.30f/30i/30killustrate thesame bead3051a/3051din a compressed state, thus, it is elongated along the beads BL axis as previously described inFIGS.10dand10e.FIG.30gillustratesouter bead sleeve3080 on whichouter bead3051aand/or3051dmay be coupled.
Outer beads3051a/3051dandmiddle beads3051b/3051ccomprisebead hub3056 andannular structure3057 coupled via only 2spokes3058a/3058bterminating onannular structure3057 proximally ofbead hub3056. This configuration may allow lysingrod3060 to move closer to tissue located distally to deliver more concentrated electrosurgical energy when the most distal portion of outer beadannular structure3057 is inhibited in its distal progress by dense/fibrous tissue. In some embodiments, spokes may comprise a different material from the bead hub. Such material may be more flexible to allow for greater movement of lysingrod3060. Alternatively,spokes3058a/3058bmay comprise the same material and the flexibility may be provided by altering the thickness of the material.
As depicted inFIGS.30a-k, in order to prevent lateral movement of middle beads, lysingrod3060 may be deformed prior to coupling with a middle bead sleeve such that the outer diameter of lysingrod3060 may couple via friction fit with the inner tunnel surface ofmiddle bead sleeve3081. In alternative embodiments, lysing tip3010 may comprise protuberances positioned on/coupled to lysingrod3060, one protuberance, for example, may be positioned on each side of eachmiddle bead3051c. In some embodiments,protuberance3065 may be positioned to face in any direction, including distally and proximally. Protuberances may serve to prevent or limit lateral movement ofmiddle beads3051b/3051con the lysingrod3060 and/or may, depending upon a protuberance pair's distance from a bead, serve to limit or prevent rotation of beads around the axis of lysingrod3060. In alternative embodiments, one or more spacers (and such as those inFIGS.11a-11e, spacers1162) may be used in place ofprotuberances3065. Alternatively,middle bead sleeves3081 may be more loosely coupled with lysingrod3060 so as to allow for rotation ofmiddle bead sleeve3081 thereon, and thereby allow for at least some rotation of their corresponding beads on lysingrod3060.
InFIG.30b, the end tip ofsupport member3070 may be coated with a non-conductive coating, thus, the area ofrelative protrusion3001 may be wider and may perform more blunt dissection than if the end tip were not so coated.
In alternative embodiments, the sleeve may be configured to have a single cone-shaped tunnel that tapers and may engage coupling tip (similar totunnel2786′ inFIG.27j) from a larger dimension on the outer side of bead to a smaller dimension toward the inside of the bead.
As depicted inFIGS.31a-e, alternative embodiments are contemplated in which free-floating lysing tips may instead be modified so as to be coupleable with actuation rod pairs3121/3123 and3122/3124 and/or one ormore cannulas3131 and/or3132 as set forth herein such that the free-floating lysing tips become non-free-floating lysing tips, as shown inFIGS.31a-e. The figures only differ from one another as to the style of bead. In all configurations, bead length may be limited to ensure that lysing tip may rotate sufficiently into a delivery configuration that permits entry and egress of the lysing tip through an outer cannula and/or an entrance incision.FIGS.31aand31bdepict beads3151e-hwhich may be similar or identical to the middle beads ofFIG.28, namely2851b/2851c.FIG.31cdepictsbeads3151i-L which may be similar or identical to the middle beads ofFIGS.27a-j, namely2751b/2751c.FIG.31ddepictsbeads3151m-pwhich may be similar or identical to the middle beads ofFIGS.29a-f, namely2951b/2951c.FIG.31edepictsbeads3151q-twhich may be similar or identical to the middle beads ofFIGS.30a-k, namely3051b/3051c.Support member3170 is coupled to the lysing rod supporting the beads.
Any of the configurations ofFIGS.31a-emay comprise canal(s)3104 (shown inFIG.31aonly) which may be positioned to supply one or more fluids to the surgical site around or near lysing tip3110 via a port located adjacent to the internal device cannula and/or lysing tip.Canal3104 may be configured to be extended and withdrawn as needed. In alternative embodiments, other fluids that may pass downcanal3104 may include, but not be limited to, cold nitrogen gas, fluorocarbons, etc., which might cool and/or freeze tissue to alter it in a desired fashion.
FIGS.32a/32b/32cillustrate a tissue modification tip (TMT)system3200 comprising center-mountedactuation rod3221,side actuation rod3222 coupled toproximal actuation rod3224,inner cannula3231 andouter cannula3232 and aTMT3211 comprisingenergy window array3213 andtip cover3212.FIG.32billustrates the tip in the intermediate position between the delivery and treatment configurations.FIG.32cillustrates the tip recessed withininner cannula3231. In alternative embodiments,TMT3211 may be configured such that it may not be able to recess withininner cannula3231. Isolated energy window(s)/termini3213′ may be any shape or configuration of shapes so long as they are electrically isolated relative to the tissue being exposed.
In some embodiments,energy window array3213 may comprise multiple isolatedenergy window termini3213′ through which energy is discharged to multiple locations on the exposed tissue at the same time. The tip of each isolatedenergy window termini3213′ may extend above the top surface ofcover3212 to attain a desired effect and/or be slightly recessed relative to cover3212. The energy discharged may be electrosurgical energy of any type or, more specifically, may be ‘coagulation’ energy waveforms that are designed for an intended effect, for example, to incapacitate sweat glands and/or to tighten tissue, and the like. The energy delivered throughenergy window array3213, which as inFIG.32amay be electrode termini, may be pulsed in order to create, as the TMT is in motion, intermittent islands of undamaged tissue to feed and nourish the damaged tissue areas back to health. For example, the electrosurgical generator may be programmed to deliver 120 watts of ‘coag’ energy with a 40% duty cycle of 80 ms ON and 120 ms OFF. These settings might seem high if they were considered to be applied to a high density discharge device such as a bovie needle tip or a bovie paddle. However, 120 watts of ‘coag’ power pulsed at a 40% duty cycle applied over 6 termini may yield an energy distribution per electrode termini of under 8 watts.
In some embodiments, each of the energy window/termini3213′ may be coupled with one another and with a common energy source so as to each deliver the modality of energy. Alternatively, one or more of the energy windows/termini3213′ may be isolated both physically and electrically and/or otherwise energetically such that different modalities of energy may be created and/or delivered through each window/termini as desired.
In alternative embodiments,TMT3211 may be configured to be free-floating and couple with a grasping/control instrument as disclosed inFIGS.33a-f. Although, as discussed below,energy window3312 does not comprise termini, this energy window may be replaced with energy window termini as shown inFIG.32a. Similarly, the energy window termini shown inFIG.32a, may be replaced with thebar energy window3312 as depicted inFIG.33a-f.
System3200 may comprise canal(s)3204 which may be positioned to supply one or more fluids to the surgical site around or nearTMT3211 via a port located adjacent to the internal device cannula and/or lysing tip (show inFIG.32aonly).Canal3204 may be configured to be extended and withdrawn as needed. In alternative embodiments, other fluids that may pass downcanal3204 may include, but not be limited to, cold nitrogen gas, fluorocarbons, etc., which might cool and/or freeze tissue to alter it in a desired fashion.
FIG.33 depicts aTMT system3300 comprising a free-floating tissue modification tip (TMT)3311 that may couple to grasping/control instrument3391. In this embodiment, graspingtab3318 may be coupled to one ormore energy windows3312 that may be positioned to face an upper and/or lower tissue plane that may have already been lysed/dissected.Cover3313 may have one ormore windows3313′ that may comprise one ormore bars3305 or other structural elements configured to separate anelongated energy window3312 into a plurality of isolated energy windows. Althoughelongated energy window3312 is in the shape of a bar, a wide variety of alternative shapes and sizes of energy windows and/or structures for defining emission regions of energy windows may be provided as desired. In some embodiments,cover3313 may be formed with a plurality of circular openings such thatelongated energy window3312 may be functionally similar or equivalent to the energy windows depicted inFIG.32.Cover3313 may be over-molded ontobaseplate3315. In alternative embodiments, the region ofenergy window3312 may comprise one or more (a plurality of) energy emitters positioned in a manner to optimize the intended tissue modification effect.Grasping tab3318 may be coupled with a grasping/control instrument through which energy may flow through toenergy window3312.Grasping tab3318 may be coupled at the receiving slot3397 between upper andlower jaws3393/3394 respectively.
For example as shown inFIG.33a,energy conduit3309 may be coupled withTMT3311. Such an energy conduit may extend fromenergy window3312 and through, for example, graspingtab3318 or otherwise throughbase plate3315 ofTMT3311.Energy conduit3309 may in some embodiments extend through an opening and/or tunnel formed in grasping/control instrument3391. Alternatively,energy conduit3309 may extend fromTMT3311 up through a cannula (not shown) through which graspingcontrol instrument3391 may be delivered.
In alternative embodiments, theTMT system3300 may be configured in any manner to accommodate the delivery or creation of any energy modality including, but not limited to, laser, intense pulse light, resistive heating, radiant heat, thermochromic, ultrasound, mechanical, and/or microwave. In some embodiments, the particular type of energy may be generated away from the TMT device and delivered to theTMT tip3311 via one ormore conduits3309. Alternatively, the TMT or the assembly supporting the TMT may contain components for example, at or nearenergy window conduit3315, that when activated with another energy, for example, AC and/or DC power and/or laser, may generate the desired energy type at theTMT energy window3312. In some embodiments, these energy modalities may be delivered through or components that generate a particular energy type inTMT3311 powered through graspingtab3318, which energy may be delivered into/onto the one ormore energy windows3312. In some embodiments, such energy may be delivered by providing one or more energy delivery conduits such as3309.
A tipenergy window tongue3319 may be formed intip3311. For example, tip energy window conduit(s)3304mmay terminate at a proximal end of agrasping pad3318. Alternatively, a tongue or the like may be formed in a grasping/control instrument and configured to be received in a corresponding slot/conduit formed intip3311. Acorresponding instrument3391′ energy window slot or conduit(s)3304fmay terminate within one or bothjaws3393/3394 or withininstrument3991′ (lower jaw3394 is not shown to facilitate viewing of other components). Thus, oncejaws3393/3394 have grasped or is about to grasp graspingpad3318, the one or more energy-related conduits3304/3304amay be aligned to allow for delivery of a desired form of energy therethrough. In some embodiments, a portion of one or both of the energy window conduits may protrude from either the tip or the instrument such that the protruding portion may be received in a corresponding female portion of the energy window conduit to form a secure connection. Thus, in the depicted embodiment, protrudingtongue3319 extends from the proximal portion ofgrasping pad3318 and is configured to be received within a distal portion of instrumentenergy window conduit3304fformed within a distal portion ofinstrument3391′ adjacent tojaws3393/3394 and/or receiving slot3397 ofgrasper3391′.
In the depicted embodiment,3347 represents an antenna configured to deliver a signal to a receiver unit.Antennae3347 may be located withinhole3355b. In some embodiments,antenna3347 may comprise radiofrequency identification (RFID) TAG. In some embodiments the RFID tag may comprise an RFID transponder. In other embodiments the RFID tag may comprise a passive tag. It should be understood thatantenna3347 is not depicted in every one of the other figures; any of the embodiments described herein may comprise one or more such elements. Other embodiments may comprise one or more antenna on any other suitable location on the embodiment, including but not limited to on the TMT or grasper tip or shaft. In embodiments in whichantenna3347 comprises an RFID transponder, the RFID transponder may comprise a microchip, such as a microchip having a rewritable memory. In some embodiments, the tag may measure less than a few millimeters. In some embodiments a reader may generate an alternating electromagnetic field which activates the RFID transponder and data may be sent via frequency modulation. In an embodiment, the position of the RFID tag or other antenna may be determined by an alternating electromagnetic field in the ultra-high frequency range. The position may be related to a 3 dimensional mapping of the subject. In an embodiment the reader may generate an alternating electromagnetic field. One or more receiver units may be set up to receive the signal from the tag. By evaluating, for example, the strength of the signal at various receiver units, the distances from the various receiver units may be determined. By so determining such distances, a precise location of the lysing tip relative to a patient and/or a particular organ or other surgical site on the patient may be determined. In some embodiments, a display screen with appropriate software may be coupled with the RFID or other localization technology to allow a surgeon to visualize at least an approximate location of the tag/antenna, and therefore the lysing tip, relative to the patient's body.
Some embodiments may be further configured such that data from the antenna(s) may be used in connection with sensor data from the device. For example, some embodiments comprising one ormore sensors3348 may be further coupled with one or more RFID tags. One ormore sensors3348 may be located within one ormore holes3355aor may be located on any other suitable location on the embodiment, including but not limited to on the TMT or grasper tip or shaft. As such, data from the one or more sensors may be paired or otherwise used in connection with data from the one or more RFID tags or other antennas. For example, some embodiments may be configured to provide information to a surgeon regarding one or more locations on the body from which one or more sensor readings were obtained. In some embodiments, temperature sensors may include thermistors and/or thermocouples. To further illustrate using another example, information regarding tissue temperature may be combined with a location from which such tissue temperature(s) were taken. In this manner, a surgeon may be provided with specific information regarding which locations within a patient's body have already been treated in an effective manner and thus which locations need not receive further treatment using the device.
In some such embodiments, a visual display may be provided comprising an image of the patient's body and/or one or more selected regions of a patient's body. Such a system may be configured so as to provide a visual indication for one or more regions within the image corresponding to regions of the patient's tissue that have been sufficiently treated. For example, a display of a patient's liver may change colors at locations on the display that correspond with regions of the liver that have experienced a sufficient degree of fibrosis or other treatment. Such regions may, in some embodiments, be configured such that pixels corresponding to particular regions only light up after the corresponding tissue in that region reaches a particular threshold temperature.
Such sensor3348 may be coupled with an antenna, which may send and/or receive one or more signals to/from a processing unit. Alternatively, or additionally, data from such sensors resulting from tissue and/or fluid analysis using such sensors may be stored locally and transmitted later. As yet another alternative, such a signal may be transmitted following surgery. In such implementations, the signals need not necessarily be transmitted wirelessly. In fact, some embodiments may be configured to store data locally, after which a data module, such as a memory stick, may be removed from the device and uploaded to a separate computer for analysis.
In alternative embodiments which may be helpful for skin/cosmetic procedures, the TD tip and/or the anticipated and/or previous paths may be visualized using for example an internal camera such as an endoscopic or laparoscopic camera, and/or an external camera such as an infrared camera, (for example, a FLIR camera), an RFID tag or other antenna. In some implementations, such a device or devices may be positioned on the TD. In other implementations such a device or devices may be separate from the TD. A real time display may be created using the data of the cameras and/or antennae and/or tags, for example, showing the exact location of the tip and the during- and post-passage temperature effects. In alternative embodiments, the software presenting the visual information may hold (or slow the decay back to the body temperature) the color (designating temperature) at its maximum value during the remainder of the procedure so that the surgeon will know where the TD tip has been.
In some embodiments, themodular TMT3311 may be used in a surgical procedure similar to that shown inFIGS.35a-f. In such embodiments, it may be helpful to form a protrusion on the top and/or bottom oftab3318. This may allow for rotation ofTMT3311 while it is in the jaws of asuitable instrument3314g/3390 similar to engagement betweenprotrusions3570t′ and3570b′ withjaws3593 and3594 respectively as depicted inFIG.35a-35f.
FIGS.34a-34icomprises dissector/tissue clamp system (D-TC)3400 that is configured to be deployed throughcannula3432 in a deployment configuration in which two opposingportions3405a/3406aof D-TC tip3410 extend substantially parallel to the axis ofcannula3432. More particularly in the depicted embodiment D-TC tip3410 comprises afirst portion3405athat nests with asecond portion3406ain the deployment configuration.First portion3405ais configured to pivot with respect tosecond portion3406awhen D-TC tip3410 is reconfigured from its deployment (also a treatment-clamping configuration) to one of its other treatment configurations. The deployment configuration is depicted inFIGS.34c/34d. A first treatment configuration is shown inFIG.34a; this treatment configuration may be referred to herein as treatment-dissecting configuration which may correspond with treatment configurations of other embodiments previously described. A second intermediate treatment configuration is shown inFIG.34b; in this configuration, twotip portions3405a/3406aare angled with respect to one another to prepare for capturing a vessel and/orduct8. A third treatment configuration is shown inFIG.34c; in this configuration, the duct and/orvessel8 may be clamped in between the two tip portions (not shown). After performing this treatment, the D-TC tip3410 may be withdrawn intocannula3432 in this same configuration after the duct/vessel8 has been severed. Thus, the configuration depicted inFIG.34cmay also be considered a deployment configuration once the duct/vessel8 has been severed.FIG.34bdepicts D-TC tip3410 as it is being reconfigured between deployment and treatment configurations or vice versa. As previously described, this intermediate configuration may also be considered a treatment configuration. For example, the configuration depicted inFIG.34bmay be used to treat tissue positioned adjacent to one or both of thetip portions3405a/3406awithout clamping/closing the jaws completely in some implementations. The pivoting of thetip portions3405a/3406amay be done by using one or more control arms. In the depicted embodiment, thefirst control arm3420 may be coupled at apivot point3420′ betweenfirst portion3405aandsecond portion3406a. Thus, by advancing or retractingcontrol arm3420,first portion3405aandsecond portion3406amay be open and closed like jaws. Additional control arms may be used in some embodiments to passively control the positioning of the two tip portions. Thus,upper control arm3421 may be pivotably coupled withfirst portion3405aandlower control arm3422 may be coupled withsecond portion3406a. Upper andlower control arms3421 and3422 respectively may be pivotably coupled at their opposite ends atpivot base3420′ coupled to the inner sides of each first andsecond portion3405a/3406a. Theactive control arm3420 may extend through the inner/device cannula3431 and may be manually controlled by a surgeon. In some embodiments, theactive control arm3420 may be operably coupled with an actuation component such as a control handpiece.
As depicted inFIG.34f,first portion3405aandsecond portion3406amay comprisenonconductive covering3405band3406brespectively which each are configured to receiveelectrode3405eand3406erespectively and their electrode segment(s).Pivot7 and7′ in the electrodes offirst portion3405aandsecond portion3406amay be coupled to controlarm3420. Additionally, pivots3416 and3416′ positioned onelectrodes3405e/3406emay be coupled withupper control arm3421 andlower control arm3422 respectively.FIG.34gdepicts a rear view of all components coupled together.
In an example of a method for treating tissue using the system ofFIGS.34a-34i, the D-TC tip3410 may first be delivered throughcannula3432 in its delivery configuration as shown inFIG.34d. D-TC tip3410 may then be advanced through the distal end ofcannula3432 as shown inFIG.34c. The opposing portions or jaws of the D-TC tip3405a/3406amay then be opened or at least partially opened as inFIG.34b. If it is desired to use D-TC tip3410 as a dissector/lysing tip, the opposingportions3405a/3406amay be fully opened such that they are aligned perpendicular to or at least substantially perpendicular to the axis of the cannula as shown inFIG.34a. D-TC tip3410 may then be used in any of the procedures as previously described. If, on the other hand, it is desired to use D-TC tip3410 in order to clamp/seal a blood vessel orduct8, the open opposingjaws3405a/3406amay be positioned about a blood vessel or duct8 (as shown inFIG.34b). In some such implementations, the opposingtip portions3405a/3406amay not be fully opened as shown inFIG.34a. The opposingjaws3405a/3406amay then be at least partially closed onto the blood vessel orduct8 in order to clamp the blood vessel and then electro-cut/electro-coagulate the blood vessel orduct8 into opposing severed ends and/or a crushed/coagulated central portion of the blood vessel with opposing ends.
FIG.34hdepicts a bipolar embodiment ofsystem3400 that includes the D-TC tip3410b.Upper portion3405a′ is configured to be electrically isolated fromlower portion3406a′ including thecontrol arm3420bandmiddle hinge3420b′.Upper portion3405a′ is coupled toenergy conduit3468nwhilelower portion3406a′ is coupled toenergy conduit3468p.Energy conduits3468n/3468pmay lead proximally and may enter and exit throughholes3431hininner device cannula3431. D-TC tip3410bmay be used in its open/treatment configuration as shown inFIG.34hto dissect tissues and tissue planes. When upper andlower portions3405a′ and3406a′ are in the closed or substantially closed position as shown inFIGS.34b/34c,system3400 may be used to clamp/seal a blood vessel or duct.
FIG.34idepicts an alternative embodiment that is similar to the embodiment depicted inFIG.34h, however, it is configured such that every other lysing segment may be of a polarity opposite to the polarity of its adjacent lysing segment at any one time. In some embodiments, each of 5 lysing segments3403a-3403emay be electrically isolated from one another.Energy conduit3468n′ may be electrically coupled to 2lysing segments3403b/3403dwhileenergy conduit3468p′ may be electrically coupled to 3lysing segments3403a/3403c/3403e.
FIGS.35a-35fdepict yet another embodiment of aCDTD system3500. However, as previously mentioned, other embodiments are contemplated in whichsystem3500 need not utilize a cannula and therefore may be considered a non-CDTD system.System3500 comprises alysing tip3510 that is configured to be completely separable from any other element of the system and may therefore be referred to herein as a “free-floating” lysing tip.Lysing tip3510 may comprise a plurality of beads3551a-dandrecessions3502 between each bead pair. Lysing member3560 (not visible, as covered byspacers3561a/b/c), which in the depicted embodiment comprises a lysingrod3560, is enclosed or may be partially enclosed byspacers3561a/3561b/3561cpositioned inrecessions3502, as previously described. Each of the portions of lysingmember3560 extending betweenadjacent beads3551a/b/c/ddefines a lysing segment.
As also previously mentioned, a grasping/control instrument3590 may extend through acannula3532 to allow for grasping and/or control of lysingtip3510 during an electrosurgical procedure. Grasping/control instrument3590 may comprise one or more jaws configured to couple withsupport member3570. As previously mentioned, in the depicted embodiment,support member3570 comprises a bow shape extending between opposing ends of thesupport member3570 and is coupled with lysing member/rod3560 at or near such opposing ends.
In the depicted embodiment, grasping/control instrument3590 comprises anupper jaw3593 and alower jaw3594. One or both of these jaws may comprise a projection or opening configured to facilitate coupling with lysingtip3510 by way of a mating opening/projection formed on thelysing tip3510. Thus,support member3570 comprises anupper projection3570t′ and alower projection3570b′. One or both of these projections may comprise a faceted and/or keyed shape to facilitate coupling of lysingtip3510 withinstrument3590 in a particular rotational orientation. Preferably, this shape allows for repositioning of lysingtip3510 at any of a plurality of preconfigured rotational positions. Thus, as shown inFIG.35d,upper projection3570t′ comprises a plurality of flattened or faceted surfaces that may mate with a corresponding plurality of flattened or faceted surfaces formed within anopening3593hformed in a lower surface ofupper jaw3593. A variety of alternative non-circular projection/opening pair shapes will be apparent to those of ordinary skill in the art after having received the benefit of this disclosure.
In some embodiments, one of the projection/opening pairs may be configured to lock the lysing tip in a particular rotational orientation and the other may be configured to allow the lysing tip to rotate while the projection is seated within the opening. For example, as also shown inFIG.35d,lower projection3570b′ may comprise a rounded and/or smooth shape to allow for rotation when positioned within a corresponding opening (not shown in the figures) formed within an upper surface oflower jaw3594. By providing one projection/opening pair that allows for rotation and another than locks the lysing tip in a particular rotational orientation, a surgeon may be able to release the locking projection/opening coupling while maintaining the rotating projection/opening pair coupling, rotate the lysing tip, and then re-lock the lysing tip in a different rotational orientation without completely releasing the lysing tip from the instrument.
However, a wide variety of alternative embodiments are contemplated. For example, although the protrusions are depicted inFIGS.35a-35fas formed on thelysing tip3510, in alternative embodiments they may instead be formed on the grasping/control instrument3590 and the openings instead formed on thelysing tip3510. In addition, a single projection/opening pair may be used instead of two separate pairs in some contemplated embodiments. In addition, in some embodiments, thelysing tip3510 may be configured to rotate while fully grasped byinstrument3590. In other words, both protrusion/opening pairs may be spherical and/or rounded or only a single such protrusion/opening may be used.
In an alternative embodiment,protrusions3570t′ and3570b′ may be located toward the side ofsupport member3570′ thus allowing a sharper angle between the axis of the lysing tip and the axis of the grasper/control instrument. Thus, the combined system may yield a smaller cross section during the deployment configuration through a cannula.
Yet another embodiment of a free-floatinglysing tip3610 is depicted inFIGS.36a-36e. This embodiment again comprises a plurality of beads3650 extending along a lysingmember3660 comprising a lysing rod. However, thebeads3651aand3651bare positioned in between opposing, fixedprotrusions3676aand3676bformed at opposite ends of lysingmember3660. As best seen inFIG.36d,protrusions3676aand3676bare fixedly coupled with or, in some embodiments, an integral part of,support member3670 at opposing ends ofsupport member3670. Thus, althoughinner beads3651aand3651bmay be configured to rotate, at least partially, with respect to lysingmember3660 and/or lysingtip3610,outer protrusions3676aand3676bmay instead be fixed.
As previously described, a plurality ofspacers3661a,3661b, and3661cmay be positioned in between each adjacent protrusion (such protrusion either being a bead or a fixed protrusion) along lysingtip3610. In addition, opposing ends of lysingmember3660 may be formed withcoupling tips3664 to facilitate coupling of lysingmember3660 withouter protrusions3676aand3676b.
Couplingtips3664 may have diameters larger than the inner diameter of theircorresponding tunnels3673 in outer protrusions3676a/3676brespectively. Thecoupling tips3664 may take various shapes, such as a ball, as depicted inFIG.36bor, for example, a mushroom cap. In the depicted embodiment, both of outer protrusions3676a/3676bcomprises arecess3670′ that may have a larger diameter or other largest dimension thantunnels3673 so as to accommodate/seat coupling tips3664. Couplingtips3664 may be made by, for example, liquefying the ends of lysingmember3660 by LASER and/or other heating methods. Alternatively,coupling tips3664 may comprise separate structural elements, such as screw-on nuts or the like. In some embodiments, it may be desirable to provide features and/or elements that inhibit or limit the ability of the electrosurgical energy to discharge from the opposing ends of the lysing rod. Thus, in some such embodiments,coupling tips3664 may be coated or covered with a suitable insulating material such as an epoxy with non-conductive properties.
Although in the depicted embodiment, outer protrusions3676a/3676bare fixedly attached to supportmember3670, it is contemplated that these protrusions may, in some alternative embodiments, be converted to beads by using bead structures that are loosely coupled with the ends ofsupport member3670 so as to provide for space in between these structures andsupport member3670 so as to allow for a predetermined amount of rotation of these outer protrusions/beads, similar toinner beads3651a/3651b.
Still another example of a free-floatinglysing tip3710 according to other embodiments is depicted inFIGS.37a-37e. In this embodiment, both ofouter beads3751a/3751dcomprise aninner recess3758rto allow for respective opposing portions ofsupport member3770 to nest therein. This configuration may be useful to prevent the opposing tips ofsupport member3770 from discharging electrosurgical energy in an undesirable manner because these tips are nested withinouter beads3751aand3751d. Although in the depicted embodiment opposing portions ofsupport member3770 are configured to be tightly or rigidly received withinrecesses3758r, alternative embodiments are contemplated in which one or both of these recesses may be formed slightly larger than theirrespective support member3770 arms to allow for a predetermined amount of rotation. For example, by adjusting the “height” ofrecesses3758r(defined between upper and lower surfaces of lysingtip3710 perpendicular to the length ofouter beads3751aand3751dbetween their respective leading and trailing ends), rotation may be allowed along an axis defined by lysingmember3760. However, by adjusting the length and/or depth ofrecesses3758r, possibly along with the dimensions of thetunnels3758hformed therein, rotation along other axes may be permitted, such as rotation along an axis normal to the axis of the lysing member3760 (resulting in swinging of the leading ends of theouter beads3751aand3751dto the left and right).
As previously described, a plurality of inner beads are also formed along lysingmember3760, namely,inner beads3751band3751c. Theseinner beads3751band3751ccomprise a flattened trailing end positioned adjacent to a distal portion ofsupport member3770. As also previously described, in some embodiments, the distance betweensupport member3770 andinner beads3751band3751cmay be selected so as to allow a predetermined amount of flexing of lysingmember3760 during an electrosurgical procedure.
In addition, opposing ends of lysingmember3760 may be formed withcoupling tips3764 to facilitate coupling of lysingmember3760 withouter beads3751aand3751d.Lysing member3760 may extend throughtunnels3758hextending throughouter beads3751aand3751d. As shown inFIG.37e, on the outer side ofouter beads3751aand3751d, a secondary recess and/orledge3751L may be formed so as to allowcoupling tips3764 to be received within this recess and engageledge3751L without enteringtunnel3758h.
Finally, a plurality ofspacers3761a,3761b, and3761cmay be positioned in between each adjacent bead along lysingtip3710.
Another example of a free-floatinglysing tip3810 is shown inFIGS.38a-38c.Lysing tip3810 is depicted coupled with a grasping/control instrument3890a/binFIG.38a.Lysing tip3810 comprises a plurality ofbeads3851 positioned along a lysingrod3860. Although each ofbeads3851 comprises a frusto-ellipsoidal shape having respective flattened trailing ends, any of the other bead shapes disclosed herein may be substituted for these beads as desired in alternative embodiments.Lysing tip3810 differs from the previously-described embodiments in that lysingrod3860 comprises opposingcoupling tips3869 configured to facilitate coupling of lysingtip3810 with one or two grasping/control instruments and corresponding holes orrecesses3891h. For example, some embodiments may comprise a grasping/control instrument comprising opposingarms3891L and3891R comprised of receiving holes orrecesses3891hat the distal ends which are configured to receive and capture lysingrod coupling tips3869. Opposingarms3891L/3891R may in some embodiments comprise jaws that may be selectively moveable relative to one another. Thus, a surgeon may open these arms/jaws to position them at opposite ends of lysingtip3810 adjacent tocoupling tips3869 and then closearms3891L/3891R such thatcoupling tips3869 may be trapped within a corresponding shaped hole and/orrecess3891hplaced in the tips of the jaws of one or more grasping instruments on closure. Alternatively,arms3891L/3891R may extend from distinct grasping control instruments that may use lysingtip3810 to perform an electrosurgical procedure in unison.
FIG.38bdepicts a detailed view of the interface between modulargrasping instrument3814g, distal tip ofshaft3896 andpushrod3897 of a surgical instrument, andtip3814ttogether, the modularsurgical tool3814. As shown in this figure the distal end ofpushrod3897 may comprise alocking feature3898.Locking lumen3899′ comprises aslot3899sconfigured to receivelocking feature3898 at a predetermined rotational configuration. Upon aligninglocking feature3898 withslot3899s,pushrod3897 andshaft3896 may be advanced intolocking lumen3899′. After advancingpushrod3897 to terminal end of slot,pushrod3897 and its accompanyingpushrod locking feature3899nmay be rotated to lockpushrod locking feature3899nin place within lockingchamber3899n′. In some embodiments, the extent of the rotation of lockingfeature3898 within lockingfeature chamber3898′ and/orpushrod locking feature3899nmay be the same as the extent of rotation of lockingfeature3898 which may in some embodiments be 90 degrees. In some embodiments,pushrod locking feature3899nmay comprise a plate or an elongated box or any other feature lacking rotational symmetry about theaxis pushrod3897. Lockingchamber3899n′ may comprise for example a box or other similar feature given to engagepushrod locking feature3899nupon rotation ofpushrod3897.
Lockingchamber3899n′ is coupled withcoupling rod3892 via holes which in turn may be coupled with one ormore locking teeth3895 formed within one or bothjaws3893a/3893b. Thus, upon advancing or retractingpushrod3897,coupling rod3892 advances or retracts to advance or retract locking tooth/teeth3895 so as to fix inplace support member3870 withinslot3893hofupper jaw3893a. One or both ofjaws3893a/3893bmay in some embodiments also be moveable with respect to the other jaw. In some such embodiments, the moveable jaw or jaws may be manually opened to allow for receipt ofsupport member3870 therein. The moveable jaw or jaws may then be closed and the locking tooth/teeth3895 actuated to lock the support member at a desired rotational orientation such as a delivery configuration such as depicted in38c. Then upon retracting the lysing tip into a patient's body, the lockingtooth3895 may be released to allow the lysing tip to be rotated to a treatment configuration. Such rotation may be accomplished by, for example, using an organ or another surgical instrument for leverage to reorient the lysing tip between delivery and treatment configurations.
As previously mentioned, in some embodiments,spacers3861 may be positioned in between each twoadjacent beads3851 to restrict thebeads3851 to a confined region along lysingrod3860 and/or limit or selectively facilitate rotation of thebeads3851 along lysingrod3860. Although not depicted in the drawings, in some embodiments, outer spacers may be provided in between the two outer beads and their respective,adjacent coupling tip3869. Alternatively,coupling tips3869 may be positioned to contact the outer surface of both outer beads or the tunnels (not shown) extending through the outer beads and/or the diameter of the lysingrod3860 may taper to provide for a suitable friction fit between the outer beads and the lysingrod3860.
In some implementations of methods for manufacturing thelysing rod3810 ofFIGS.38aand38b/c, lysingrod3860 may initially comprise a wire defining a cylindrical shape, or similar shape, along its entire length. Each of thevarious beads3851 and, in some embodiments,spacers3861 as needed, may then be strung along lysingrod3860 and positioned as desired. Then, in order to formcoupling tips3869, opposing ends of lysingrod3860 may be flattened and formed with a suitable hole and/or notch as desired.Lysing rod3860 may be held in place onsupport member3870 vialoop3877.
FIGS.39a-39edepicts yet another example of a modular instrument/tip3900 configured to be coupled with a surgical instrument. Modular instrument/tip3900 comprisesmiddle beads3951iandouter beads39510 coupled to lysingtip3910 that may permanently couple with amodular instrument shaft3991. As previously described in connection withFIGS.17L and17m,modular instrument shaft3991 may be reversibly coupled with a surgical instrument at its distal end such as by using a pushrod and the locking elements previously described. Once this coupling has taken place, a handle or suitable actuator may be used to reposition apiston3917pbetween a first configuration in which lysing tip is locked at a predetermined rotational configuration and a second configuration in which the lysing tip is allowed to be repositioned at any of a plurality of rotational orientations. More particularly, in the second configuration, thesupport member3970 of the lysing tip is loosely received within ahole3997 formed at the distal end ofmodular instrument shaft3991. Thus, in this configuration, lysing tip can be rotated to a delivery configuration as shown inFIG.39d. Then, upon advancingpiston3917p, the lysing tip may be locked in this position and delivered through an incision into a patient's body. After being delivered,piston3917pmay be retracted to allow the support member to slide withinhole3997 and rotate the lysing tip to the treatment configuration depicted inFIG.39cafter which thepiston3917pmay be advanced to lock the lysing tip in this position for performing an electrosurgical procedure.
As also shown inFIGS.39dand39e, some embodiments may be configured to translate a proximal movement to a distal movement at or near the lysing tip. This may be useful for example to allow for a squeezing motion of an instrument handle to be used to force an actuation member such aspiston3917p′ distally rather than proximally so as to allow a surgeon to lock lysingtip3910 in place at a desired rotational orientation. For example inFIG.39d, this may be accomplished with an lever mechanism which may comprise fulcrum3918fon which pivotslever3918wwhich is pivotably attached torods3918uand3918L that each connect todistal piston3917p′ andproximal piston3919p′ respectively. As another example inFIG.39e, this motion translation may be accomplished with a ratcheting mechanism which may comprisetoothed cog3917cpositioned in between ratchetedrods3917uand3917L. Lockingfeature3998 may reversibly couple with the distal tip of a control instrument.
FIG.40 depicts a flow chart of an optional implementation for the other implementations disclosed herein of an energy emission-sensor feedback loop4000 according to this disclosure:Step4005 may comprise: setting one or more temperatures (a desired maximal temperature threshold, or a range). In other implementations one or more such temperatures may be preset by the manufacturer.Step4010 may comprise setting one or more energy levels to lysing member(s) of a TD and/or energy window of a tissue modification tip (TMT) (a desired maximal energy threshold, or a range). In other implementations energy levels may be preset by the manufacturer.
Step4013 comprises inserting the lysing tip through an entrance incision into the patient's body. In some implementations for example,step4013 may comprise inserting the lysing tip via one or more cannulas. In some such implementations, the lysing tip may be delivered through the cannula or cannulas in a delivery configuration and be rotated/pivoted into a treatment configuration. Alternatively, the lysing tip may be inserted without using a cannula but instead a grasping/control instrument which may be a laparoscopic driver for example. In the implementations comprising 2 cannulas, the inner and outer cannulas may be inserted through the entrance wound either simultaneously or sequentially. In some implementations, the lysing tip may be free-floating such that it is inserted into the body and then coupled with grasping/control instrument after being positioned in the body. It should be understood that embodiments are contemplated wherein the dimensions of the tip relative to acannula1431 may vary as for example, as shown inFIGS.14kand14L. In other words, thelysing tip1410 in the axial deployment configuration may be unable to be received withincannula1431 such as shown inFIG.16L or may be unable to be received within an inner cannula of two delivery cannulas as shown inFIG.16k. In embodiments comprising two cannulas, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip can correspond to the larger diameter outer cannula as opposed to being limited to the smaller dimensions of the inner/device cannula. In embodiments comprising a single cannula, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip in its axial/delivery configuration only need to correspond to the size of the entrance incision. With respect to such embodiments, the single cannula may primarily serve to protect and stabilize the control rods and provide rigidity to the assembly. Upon detecting that the tip has been rotated to its treatment configuration, actuating the temperature sensors and/or temperature feedback loop.
Step4015 may comprise passing the TD or TMT through the target tissue area. In some implementations, the TD and/or TMT may comprise one or more sensors, such as temperature sensors. Alternatively or in addition, the sensor may be mounted in a position that always remains external to patient yet able to sense a residual energy release from the TD or TMT through tissue.Step4020 may comprise applying electrosurgical energy. For example, in some implementations, electrosurgical energy may be applied to one or more lysing members. In other implementations, electrosurgical energy may be applied to one or more energy windows. In some implementations, such energy may be applied to both the lysing members and/or the energy window either simultaneously or sequentially.Step4025 may comprise gathering sensor data, such as temperature data.Step4030 may comprise comparing sensor data to one or more set temperature levels.Step4035 may comprise, if the sensed temperature exceeds the threshold, reducing the amount of energy delivered through the lysing member and/or TMT.
FIG.41 depicts a flow chart of an implementation of a method for separating and/or modifying tissue using a TD. In this particular implementation, the use of combined data from the TD generated from at least the temperature sensor and the antenna(s) may be used to provide suitable feedback to a user during treatment. In some implementations, the TD Wand may comprise a tip comprising a plurality of protrusions. One or more lysing member(s) may be positioned between at least two adjacent protrusions among the plurality of protrusions. A temperature sensor may be positioned on the TD. The temperature sensor may be configured to sense a temperature of at least one of tissue and fluid adjacent to the TD during an operation. The fluid of which a temperature reading is taken may comprise, for example, fluid from adjacent tissue(s) and/or fluid introduced during the procedure by way of the TD and/or another device or procedure. The TD may also comprise an antenna(s) such as an RFID tag positioned on the TD. In some implementations, the antenna(s) may be positioned on the tip and/or distal end of the shaft, such as on a bottom surface of the tip and/or distal end of the shaft. The antenna(s) may be configured to provide location data regarding a location of the TD, such as a particular portion or region of the TD for example, during an operation or procedure. Althoughmethod4100 is shown in the figure beginning withstep4105, it should be understood that any of the preliminary steps described above in connection with other implementations may be performed inmethod4100 as well. For example, one or more of steps (4005-4035) frommethod4000 may be performed inmethod4100 if desired. In some implementations,step4105 may comprise: receiving data from the TD temperature sensor and/or a sensor not mounted on the TD but perhaps external to the patient.Step4110 may comprise receiving data from the antenna(s) such as RFID tag data.Step4115 may comprise combining the data generated from at least the temperature sensor and the antenna(s). In some implementations, the data from the temperature sensor and the antenna(s) may be combined before it is received. In other words, a step of “receiving combined data from the TD generated from at least the temperature sensor and the antenna(s)” may comprise receiving precombined data (data from the temperature sensor and the antenna(s) that was combined before it was received) or, alternatively, may comprise separately receiving temperature data and antenna(s) data that may be combined to allow for one or more particular features or functionalities. The combined data may be used to allow a surgeon or other user to determine one or more regions within a patient's body that have been adequately treated using the TD. For example, in some implementations, the combined data may allow a user to visualize one or more regions within a patient's body, such as one or more regions that have been sufficiently treated. This may be accomplished, for example, by creating an image corresponding with one or more regions of a patient's body. Such image or images may be highlighted, receive color changes, or otherwise modified on a display to indicate to the user which regions have been adequately treated. In some implementations, such regions may correspond with regions comprising tissue that has reached a predetermined threshold temperature.
One implementation of amethod4200 according to this disclosure for accessing an organ and/or target tissue with the assistance of a TD is shown inFIG.42. In some implementations, surgeon(s) may need to access tissue and/or an organ to repair or treat it. In some implementations, the skin surrounding the anticipated entrance wound for the surgical area may be cleansed by, for example, with isopropyl alcohol (degreaser) followed by germicidal chlorhexidine scrub. Then, a local anesthetic may be applied (such as by injecting) 1% lidocaine+1:10,000 adrenaline to the skin. Althoughmethod4200 is shown in the figure beginning withstep4205, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/ormethods4000 and4100 may be performed inmethod4200 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40 and/or steps4105-4140 of the method depicted inFIG.41 may also be included in the method depicted inFIG.42.
Step4205 may comprise, for minimally invasive procedures or minimally invasive entrance wounds, performing a limited incision capable of accommodating the most minimal dimension of a tip that will pass and/or cannula that will pass into the entrance incision For example, as previously discussed, the incision may have a length that is the same or substantially the same or slightly larger than the width of the tip and/or the diameter of the cannula.Step4205 may be performed with, for example, a #15 Bard-Parker™ Scalpel. This incision may be deepened by scalpel, scissors or other surgical instrument to enter the desired body structure or cavity. For larger approaches, such as open abdominal surgery ortrauma surgery step4205 may comprise the initial skin opening or body cavity opening steps of such a procedure. In some implementations,step4205 may comprise making the skin incision using the lysing member comprising lysing member(s) of the TD.Step4210 may comprise applying one or more fluids to the tissues. In some implementations,step4210 may comprise applying fluids to the target tissue(s). In some implementations, embodiments with canals that may carry fluids may be used as described herein, for example,canal304 ofFIG.3a, and/orcanal1404 ofFIG.14d. In alternative embodiments, other fluids that may pass downcanal304 may include, but not be limited to, cold nitrogen gas, fluorocarbons, etc., which might cool and/or freeze tissue to alter it in a desired fashion. In some implementations,step4210 may comprise applying fluids to the tissues to be traversed en route to the target tissue, in addition to, or as an alternative to applying fluids directly to the target tissue(s). This step may be performed using forexample canals304 or1404 depicted inFIGS.3aand14drespectively. In some implementations, the fluid(s) may comprise water. In some implementations, the fluid(s) may comprise an ionic fluid, such as a saline solution. The fluid(s) may be applied to the tissue via, for example, injection, or TD fluid port or via a separate cannula or catheter or via pouring or via spray. In some implementations, the fluid(s) may comprise an ionic fluid and an anesthetic, such as a tumescent anesthesia. Non-ionic fluids may be used in other implementations; such fluids may become more ionic by diffusion of some of the patients' ions present in the surgical field. In some implementations step4210 may comprise applying one or more fluids that serve as an ionic fluid, and/or an anesthetic, and/or adrenaline. In some cutaneous implementations, the fluid(s) may comprise a Klein and or other tumescent formula. In some implementations, the Klein formula and amount used may be about 100 cc of Klein Formula with saline, 0.1% lidocaine, epinephrine 1:1,000,000, and NaHCO3@5 meq/L. Those of ordinary skill in the art will appreciate that this step will most typically be followed in connection with procedures involving skin tissues. Other procedures may not require performing this step.
Step4213 comprises inserting the lysing tip through an entrance incision into the patient's body. In some implementations for example,step4213 may comprise inserting the lysing tip via one or more cannulas. In some such implementations, the lysing tip may be delivered through the cannula or cannulas in a delivery configuration and be rotated/pivoted into a treatment configuration. Alternatively, the lysing tip may be inserted without using a cannula but instead a grasping/control instrument which may be a laparoscopic driver for example. In the implementations comprising 2 cannulas, the inner and outer cannulas may be inserted through the entrance wound either simultaneously or sequentially. In some implementations, the lysing tip may be free-floating such that it is inserted into the body and then coupled with grasping/control instrument after being positioned in the body. It should be understood that embodiments are contemplated wherein the dimensions of the tip relative to a cannula may vary as for example, as shown inFIGS.14kand14L. In other words, thelysing tip1410 in the axial deployment configuration may be unable to be received withincannula1431 such as shown inFIG.14L or may be unable to be received within aninner cannula1431 of twodelivery cannulas1431 and1432, as shown inFIG.14k. In embodiments comprising two cannulas, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip can correspond to the larger diameter outer cannula as opposed to being limited to the smaller dimensions of the inner/device cannula. In embodiments comprising a single cannula, this may be useful because if the lysing tip does not require substantial protection and can remain outside the inner cannula's lumen, then the critical dimensions of the lysing tip in its axial/delivery configuration only needs to correspond to the size of the entrance incision. With respect to such embodiments, the single cannula may primarily serve to protect and stabilize the control rods and provide rigidity to the assembly. Such embodiments may be useful for cosmetic procedures within the skin, for example, but not limited to, for face lifting and/or cellulite treatment.
Step4215 may comprise a first sub-step that may be to activate the electrosurgical generator to cause cutting and/or a blend of cutting and coagulation energies to flow to the lysing member(s). The second sub-step may be passing the TD through the various layers of tissue to create a path to a target organ. In some implementations, creating a path to a target organ or other target tissue may comprise creating a path from the incision to the target organ or other target tissue and/or creating a path around the target organ or other target tissue to allow for access to other regions of the target organ or other target tissue. In some implementations, the lysing member(s) may be used to induce fibrosis along the path, including along a path that may traverse the perimeter of the target organ/tissue. In some implementations, the TD and/or the anticipated path may be visualized using for example an internal camera such as an endoscopic or laparoscopic camera. In some cutaneous and/or cosmetic implementations, an external camera such as a FLIR camera, an RFID tag or other antenna may be used. In some implementations, such a device or devices may be positioned on the TD. In other implementations such a device or devices may be separate from the TD. In some implementations, heat may be produced or energy may otherwise be released in the tissues through which the TD is passed. In some implementations, heating portions of the tissues the TD passes by may be undesirable. As such, in some implementations, undesirable heating of such tissues and/or adjacent tissues may be mitigated by applying a cooling step antecedent and or concurrent with energy delivery with the TD. Such steps may comprise use of one or more cooling fluids delivered via the TD or one or more separate catheters or cannulas or endoscopes. Other cooling mechanisms may comprise a dynamic cooling system wherein a cool liquid or gel is actively pumped into or through a contact cooling object.Step4220 may comprise identifying critical tissue that is not to be treated, such as important blood vessels, nerves, ducts, organs or other anatomy along the path to the target organ/tissue and/or in the area surrounding the target organ/tissue.Step4225 may comprise: adding additional fluids of the types previously described to the target and/or surrounding tissues via the TD port(s) or via one or more separate catheters or cannulas or endoscopes.Step4230 may comprise: expanding one or more regions of the path to the target tissue. In some implementations,step4230 may comprise expanding one or more path(s) from the incision to the target tissue. In some implementations,step4230 may comprise expanding a region around the target tissue such as for example, via a fanning motion. In some implementations, one or more of the other steps described herein using the TD may also be performed with a fanning motion. In implementations using TDs with axially oriented protrusions, such a fanning motion may comprise a to and fro spokewheel pattern. In implementations using TDs with nonaxially oriented protrusions, such a fanning motion may comprise a side-to-side fanning motion; one example of a fanning motion using a TD having at least one nonaxially oriented protrusion may comprise a ‘windshield wiper’ motion. In some implementations step4230 may further comprise activating the energy to the TD, for example, the energy to the lysing member(s). Alternatively, in some implementations, anadditional step4231 may be used comprising withdrawing the lysing tip and inserting and activating a TMT for a desired effect, for example, tissue modification/tightening.Step4235 may comprise: observing for bleeding from larger vessels and achieving hemostasis as needed. In some implementations achieving hemostasis may be accomplished by cautery, electrifying, ligating, or chemical methods. In some implementations, the surgeon may activate the electrosurgical coagulation energy to the lysing member(s) to achieve the hemostasis. In some implementations, one or more other devices and/or suture may be used to achieve hemostasis for larger vessels.
Generally,step4238 may comprise withdrawing the lysing tip. For example,step4238 may comprise rotating the lysing tip such that it extends axially along the lumen of the one or more cannulas or at least substantially axial to such lumen(s). In some implementations the lysing tip may be rotated at an angle with respect to such lumen so long as the lysing tip can be withdrawn through this cannula in this configuration. After rotating the lysing tip sufficiently such that it can be received within the cannula or cannulas, the lysing tip may be withdrawn through the entrance incision.
In some implementations not utilizing a cannula, the lysing tip preferably is again rotated such that the elongated axis of the lysing tip is aligned or at least substantially aligned with the direction of withdrawal. After such rotation, the lysing tip may be withdrawn through the entrance incision. In some such implementations, a surgeon may rotate the lysing tip by palpation. Alternatively, an instrument may be used to perform the rotation and may be used to withdraw the lysing tip through the entrance incision. As previously mentioned, in some implementations, a first instrument may release its coupling with the lysing tip and then a second instrument may be used to rotate and/or withdraw the lysing tip. In alternative implementations, a cord, for example, a suture and/or thread, may have been previously tied to a hole in the lysing tip and may be used to pull the lysing tip through entrance incision.
Step4240 may comprise: removing the TD with power off and suturing the wound in the standard fashion. In some implementations, the tissues traversed may require closure by suturing, stapling, gluing, and/or adhesive skin closure strips. In some implementations, organs and/or organ systems that the TD may be useful to access may include but not limited to skin, muscle, and/or parotid, and/or salivary gland, and/or thyroid, and/or lung, and/or heart, and/or gastrointestinal, and/or liver, and/or pancreas, and/or spleen, and/or gallbladder, and/or kidney, and/or adrenal, and/or prostate, and/or ovary, and/or uterus, and/or bladder, and/or vascular, and/or nervous, and/or lymph nodes and/or skeleton.
In some implementations, the TD may also aid in the treatment of trauma victims; for example, gunshot and/or blast injuries and/blunt force trauma. Such patients may be in shock and bleed to a greater degree than normal due to systemic changes, some changes of which may consume and/or alter platelets and/or clotting proteins in the blood. It may be beneficial for surgeons to reach a vigorously bleeding area more rapidly while achieving a degree of hemostasis by coagulating smaller vessels along the path to reaching said vigorously bleeding area (likely due to trauma to a larger blood vessel). The TD may have smaller vessel hemostatic capabilities when energy is applied to lysing member. Having a field of surgery with less bleeding may be beneficial to the surgeon who is working to find and repair a larger blood vessel (for example, a femoral or brachial artery). The size of the TD's lysing areas may be such that a larger vessel will not fit into the TD and thus not be affected by the TD; thus, the surgeon may feel more confident that the TD will not risk traumatizing a larger blood vessel further.
In some implementations such asmethod4300, the TD may also aid in the treatment of hernias. Generally, herniated tissues are those that may have lost firmness and may have become lax allowing one or more organs to unwantedly protrude into adjacent spaces. To treat a hernia, surgeons may make paths to the site to be treated, may remove the lax hernia sac and/or other lax/herniated tissues by dissecting around said tissue(s), and may then connect/suture the edges of healthy tissue together to re-create the original healthy tissue wall, or, if insufficient healthy tissue is present, may use mesh to connect the healthy tissue to form the new tissue wall.
One implementation of amethod4300 according to this disclosure for repairing hernias with the assistance of a TD is shown inFIG.43.
Step4331 may comprise making a path to the site of the herniated tissue.Step4331 may also comprise using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the herniated tissues and/or associated fibrous tissues and/or the surrounding tissue(s).Step4331 may be performed using, for example, needles, sutures, hooks, clamps, retractors, probes, bars, endoscopes, rakes, tubes, and/or TD.
Step4332 may comprise dissecting around the herniated tissue in order to remove it or free up adjacent structural tissue so that the TD or another instrument may cut/excise around the herniated tissues for removal. In some implementations step4331 may be performed concurrently withstep4332.Step4332 may further comprise passing the TD to at least substantially free or prepare for excision the herniated tissues and/or associated fibrous tissues from the surrounding tissues. In some implementations,step4332 may further comprise applying energy to the lysing members during this TD passage.
Step4333 may comprise excising and removing the herniated/lax tissues and/or hernia sac.
Step4334 may comprise heating the tissue surrounding the herniated tissue and/or associated fibrous tissues and/or tissue(s) that a surgeon intends to incorporate into the region to secure and/or restrain the remaining tissue into its intended and/or original place. In some implementations,step4334 may be performed using the TD, either with lysing segments of the TD or an energy window. Alternatively, the TD may be withdrawn and a TMT may be introduced having an energy window and used for this purpose.
Step4335 may comprise (if further freeing/excision appears necessary) using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught target tissue(s) while the TD may be passed to more uniformly apply energy to the target tissue via the lysing member(s) of the lysing tip and/or via the Tissue Modification Tip (TMT) or other applicable device that may induce hemostasis and/or induce postoperative fibrosis, and/or alter certain tissues.
Step4336 may comprise sewing, stapling or binding the remaining tissues and/or herniated tissues into place. If insufficient healthy tissue is present to form a proper intended tissue wall, mesh may be used to bridge the space between the healthy tissues.
Step4337 may comprise passing the TD adjacent to those tissues that have been sewn and/or otherwise bound. In some implementations,step4337 may comprise activation of the lysing member or activation of a TMT to induce supportive fibrosis.
In some implementations, organs and/or organ systems that the TD may be useful to assist in remedying a herniated state may include but not limited to muscle, and/or parotid, and/or salivary gland, and/or gastrointestinal, and/or uterus, and/or bladder, and/or vascular, and/or genitourinary.
One implementation of amethod4400 according to this disclosure for accessing the central nervous system (CNS) with the assistance of a TD is shown inFIG.44. Althoughmethod4400 is shown in the figure beginning with step4315, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod4400 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.44.
After preparing the surgical field, making the entrance incision, and introducing the TD through the entrance incision,step4415 may comprise making a path to the target tissue/organ. More particularly, in implementations accessing the brain,step4415 may comprise moving the TD through the subgaleal layer; this may allow the scalp to be retracted for better access to open the skull via bone saw and/or other tools known in the art. In some implementations step4415 may further comprise activating the lysing member to reduce bleeding from emissary blood vessels. In implementations accessing the spinal cord,step4415 may comprise moving the TD through tissue surrounding the spine. In some implementations, such movement may comprise a fanning motion.Step4420 may comprise dissecting the dura using the TD and/or identifying important blood vessels, and/or other anatomy in the area surrounding the target tissue.Step4425 may comprise: adding additional fluids of the types previously described to the target and/or surrounding tissues via the TD port(s) or via one or more separate catheters or cannulas or endoscopes prior to and/or during the application of energy by TD.Step4429 may comprise: activating the energy to the TD for example the energy to the lysing member(s).Step4430 may further comprise passing the TD around and/or through the target tissue in the CNS such as for example, via a delicate fanning motion. In some implementations, the TD and/or the anticipated path may be visualized using for example an endoscope, a fiberoptic or camera, an RFID tag or other antenna. In some implementations, such a device or devices may be positioned on the TD. In other implementations such a device or devices may be separate from the TD.Step4435 may comprise: observing for bleeding from larger vessels and achieving hemostasis as needed. In some implementations achieving hemostasis may be accomplished by cautery, electrifying, ligating, chemical methods, and/or use of a TMT. In some implementations, the lysing member(s) can be used to achieve the hemostasis. In some implementations, one or more other devices and/or suture may be used to achieve hemostasis for larger vessels.Step4440 may comprise: removing the TD with power off and suturing the wound in the standard fashion.
One implementation of amethod4500 according to this disclosure for removing tissue from a peripheral nerve such as for example tumor and/or scar tissue and/or fibrosis with the assistance of a TD is shown inFIG.40. Althoughmethod4500 is shown in the figure beginning withstep4531, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod4500 as well. For example, one or more of steps4005-4035 in the method depicted inFIG.40 may be performed inmethod4500 if desired. Similarly, one or more other steps of any of the other implementations described herein such as for example, steps4005-4045 of the method depicted inFIG.40 may also be included in the method depicted inFIG.45.
Step4531 may comprise using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the nerve and/or tissue adjacent a peripheral nerve (such as for example tumor and/or scar tissue and/or fibrosis) and/or surrounding tissue(s).Step4531 may be performed using, for example, needles, sutures, hooks, clamps, retractors, probes, bars, endoscopes, rakes, tubes, TD and/or by hand. In some implementations step4531 may be performed concurrently withstep4532.Step4532 may comprise passing the TD to at least substantially free the tumor(s) and/or scar tissue and/or fibrosis from the nerve and/or surrounding tissues. In some preferred implementations,step4532 may comprise passing the TD to free, or at least substantially, free, the tumor(s) and/or scar tissue from the nerve and/or surrounding tissues without activating the lysing segments of the TD. In other words, because of the sensitive nature of nerve tissue, it may be preferred to use the TD as a blunt dissector without using electrosurgical energy. However, additional related steps may involve use of such energy. In addition, in alternative implementations, energy may be applied to the lysing members during this TD passage.Step4533 may comprise identifying and/or testing the tissue (such as for example tumor and/or scar tissue and/or fibrosis) to determine if it has been sufficiently freed from the nerve and/or surrounding tissues for uncomplicated removal. In some implementations endoscopes and/or blunt probes and/or TD and/or surgeon's hands may be passed around the tumor and/or scar tissue and/or fibrosis to test the degree of freedom the tumor and/or scar tissue and/or fibrosis has from the nerve and/or surrounding tissues.Step4534 may comprise (if further freeing appears necessary) using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the nerve and/or tumor and/or scar tissue and/or fibrosis.Step4535 may comprise passing the TD to further free the nerve; energy may be applied to the lysing members during this TD passage (in order to attempt hemostasis and/or induce postoperative fibrosis).Step4535 may be repeated as necessary until the tumor and/or scar tissue and/or fibrosis is sufficiently freed for removal. In an implementation the TD is passed longitudinally along the nerve in a ‘stripping’ fashion, such that a longitudinal axis of the TD is at least substantially parallel to a longitudinal axis of the nerve duringstep4533. The shape of certain embodiments of lysing tips described herein may be particularly useful in allowing the tip to be moved along a nerve without causing undue damage to the nerve. More particularly, by providing smooth protrusions and recessing the sharpened or electro-cutting portions of the tip between the protrusions, the nerve may be protected from the cutting aspects of the device.
In an alternative implementation ofmethod4500, this method may be modified to allow for dissection of tissues to repair an aneurism. In such an implementation, each of the steps up to4532 may be substantially identical tomethod4500.Step4532 may instead comprise dissecting vascular and connective tissues in and around the aneurism using the TD. This step may also include sealing small peripheral bleeders from and around the aorta.Step4533 may comprise dissecting/cutting a section or sectioning the aorta with the TD.
In another alternative implementation ofmethod4500, this method may be modified to conduct a coronary artery bypass graft and/or other vascular graft. In such an implementation, each of the steps up to4532 may be substantially identical tomethod4500.Step4532 may instead comprise dissecting out the saphenous vein from a leg or other suitable vessel (e.g., infra mammary).Step4533 may comprise dissecting along the vessel to remove any adhesions and/or seal/disconnect small periphery blood vessels that may bleed and/or seal small peripheral vessels.
One implementation of amethod4600 according to this disclosure for creating a tissue flap and/or section with the assistance of a TD is shown inFIG.46. (In thismethod4600, the term ‘flap’ may include ‘section’.) In some implementations, such a flap of tissue may be used for breast reconstruction. In some implementations, such a flap of tissue is a latissimus dorsi flap. In some implementations, such a flap of tissue is a TRAM (Transverse Rectus Abdominus Myocutaneous) flap. Althoughmethod4600 is shown in the figure beginning withstep4631, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod4600 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.46.
Step4631 may comprise using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the target region of tissue to be used in creating a tissue flap and/or the surrounding tissue(s).Step4631 may be performed using, for example, needles, sutures, hooks, clamps, retractors, probes, bars, endoscopes, rakes, tubes, TD and/or by hand. In some implementations step4631 may be performed concurrently withstep4632.Step4632 may comprise passing the TD to at least substantially separate a sufficient amount of tissue to create and/or free at least a portion of the tissue flap. In some implementations,step4632 may further comprise applying energy to the lysing member(s) during this TD passage.Step4633 may comprise testing the target tissue flap to determine if it has been sufficiently freed from the surrounding tissues for uncomplicated removal (excluding its pedicle). In some implementations endoscopes and/or blunt probes and/or TD and/or surgeon's hands may be passed around the target organ/tissue to determine the degree of freedom a target flap and/or tissue has from its surrounding tissues and/or organs.Step4634 may comprise (if further freeing appears necessary) using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the target flap and/or tissue and/or other surrounding tissue while the TD may be passed to further free the target flap and/or tissue; energy may be applied to the lysing member(s) during this TD passage (in order to attempt hemostasis and/or induce postoperative fibrosis).Step4635 may comprise passing the TD (after the target flap and/or tissue has been freed and/or moved) to the tissues that were adjacent and remaining in the body, which may aid the surgeon in examining for points of further bleeding and/or for further exploration; during such passage energy may be applied to the lysing members (in order to attempt hemostasis and/or induce postoperative fibrosis). In some implementations, traditional instruments may be used to achieve hemostasis. In some implementations, one or more of these steps using the TD may be performed with a fanning motion. In implementations using TD's with axially oriented protrusions, such a fanning motion may comprise a to and fro spokewheel pattern. In implementations using TD's with at least one nonaxially oriented protrusion, such a fanning motion may comprise a side-to-side fanning motion; one example of a fanning motion using a TD having at least one nonaxially oriented protrusion may comprise a ‘windshield wiper’ motion. In some implementations, the TD may be used to create flaps in and/or from tissues and/or organs including but not limited to muscle and/or fascia, and/or fibrous tissue and/or fat and/or vascular tissues. In some implementations, the TD may be used to create flaps and/or sections in and/or from tissues and/or organs including but not limited to, lung and/or liver and/or gastrointestinal and/or genital/urinary and/or uterus and/or bladder.
One implementation of amethod4700 according to this disclosure for creating a tissue graft with the assistance of a TD is shown inFIG.47. In some implementations, such a graft of tissue may be used for reconstruction of traumatic wounds.
Althoughmethod4700 is shown in the figure beginning withstep4731, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod4700 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.47.
Step4731 may comprise using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the target region of tissue to be used in creating a tissue graft and/or the surrounding tissue(s).Step4731 may be performed using, for example, needles, sutures, hooks, clamps, retractors, probes, bars, endoscopes, rakes, tubes, TD and/or by hand. In some implementations step4731 may be performed concurrently withstep4732.Step4732 may comprise passing the TD to at least substantially separate a sufficient amount of tissue to create and/or free at least a portion of the tissue graft. In some implementations,step4732 may further comprise applying energy to the lysing members during this TD passage.Step4733 may comprise testing the target tissue graft to determine if it has been sufficiently freed from the surrounding tissues for uncomplicated removal. In some implementations endoscopes and/or blunt probes and/or TD and/or surgeon's hands may be passed around the target organ/tissue to determine the degree of freedom a target graft and/or tissue has from its surrounding tissues and/or organs.Step4734 may comprise (if further freeing appears necessary) using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the target graft and/or tissue and/or other surrounding tissue while the TD may be passed to further free the target graft and/or tissue; energy may be applied to the lysing members during this TD passage (in order to attempt hemostasis and/or induce postoperative fibrosis).Step4735 may comprise passing the TD (after the target graft and/or tissue has been freed and/or moved) to the tissues that were adjacent and remaining in the body, which may aid the surgeon in examining for points of further bleeding and/or for further exploration; during such passage energy may be applied to the lysing members (in order to attempt hemostasis and/or induce postoperative fibrosis). In some implementations, traditional instruments may be used to achieve hemostasis. In some implementations, one or more of these steps using the TD may be performed with a fanning motion. In implementations using TD's with axially oriented protrusions, such a fanning motion may comprise a to and fro spokewheel pattern. In implementations using TD's with at least one nonaxially oriented protrusion, such a fanning motion may comprise a side-to-side fanning motion; one example of a fanning motion using a TD having at least one nonaxially oriented protrusion may comprise a ‘windshield wiper’ motion. In some implementations, the TD may be used to create grafts in and/or from tissues and/or organs including but not limited to skin and/or mucosal and/or fascia, and/or connective/fibrous tissue (for example, tendon) and/or fat and/or vascular tissues. In some implementations, the TD may be used to create grafts in and/or from tissues and/or organs including but not limited to, lung and/or liver and/or gastrointestinal and/or genital/urinary and/or uterus and/or bladder. In some implementations, the TD may be used to harvest any or all of the aforementioned tissues for organ culture.
One implementation of amethod4800 according to this disclosure for removing tumor from an organ with the assistance of a TD is shown inFIG.48. In some implementations, the tumor may be incompletely removed to ‘debulk’ it and/or to prevent disease spread within the body and/or pathologic analysis. In some implementations, the tumor may be completely removed to prevent disease spread within the body and/or pathologic analysis. Althoughmethod4800 is shown in the figure beginning withstep4831, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod4800 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.48.
Step4831 may comprise using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the tumor and/or the surrounding tissue(s).Step4831 may be performed using, for example, needles, sutures, hooks, clamps, retractors, probes, bars, endoscopes, rakes, tubes, TD and/or by hand. In some implementations,step4831 may be performed concurrently withstep4832.Step4832 may comprise passing the TD to at least substantially free the tumor(s) from the surrounding tissues. In some implementations,step4832 may further comprise applying energy to the lysing segments and/or energy windows during this TD passage.Step4833 may comprise identifying and/or testing the tumor to determine if it has been sufficiently freed from the surrounding tissues and/or organ for uncomplicated removal. In some implementations endoscopes and/or blunt probes and/or TD and/or surgeon's hands may be passed around the tumor to test the degree of freedom the tumor has from its surrounding tissues and/or organs.Step4834 may comprise (if further freeing appears necessary) using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the tumor and/or the surrounding tissue and/or organ while the TD may be passed to further free the tumor; energy may be applied to the lysing segments and/or energy windows during this TD passage (in order to attempt hemostasis and/or induce postoperative fibrosis). In some implementations, traditional instruments may be used to achieve hemostasis.Step4834 may be repeated as necessary until the tumor is sufficiently freed for removal.Step4835 may comprise passing the TD (after the tumor has been removed) to the tissues that were adjacent to the tumor (and still remaining in the body), which may aid the surgeon in examining for points of further bleeding and/or for further exploration; during such TD passage, energy may be applied to the lysing segments and/or energy windows.Step4836 may comprise using the TD to subdivide portions of the tumor which may aid in extracting the tumor in pieces if the surgery is done via a minimally invasive technique. In some implementations, if the surgical incision in the body is larger, the tumor tissue may pass more freely out of the body without piecemeal removal. In some implementations, the tumor is placed in the appropriate medium for a pathologist to examine or test. In some implementations, one or more of these steps using the TD may be performed with a fanning motion. In implementations using TD's with axially oriented protrusions, such a fanning motion may comprise a to and fro spokewheel pattern. In implementations using TD's with at least one nonaxially oriented protrusion, such a fanning motion may comprise a side-to-side fanning motion; one example of a fanning motion using a TD having at least one nonaxially oriented protrusion may comprise a ‘windshield wiper’ motion. In some implementations, organs and/or organ systems that the TD may be useful to remove tumors which may include but not limited to skin, and/or muscle, and/or fibrous tissues, and/or parotid, and/or salivary gland, and/or thyroid, and/or lung, and/or breast, and/or heart, and/or nervous system, and/or spleen, and/or gastrointestinal, and/or liver, and/or pancreas, and/or gallbladder, and/or genital/urinary, and/or kidney, and/or adrenal, and/or prostate, and/or ovary, and/or uterus, and/or bladder, and/or vascular, and/or lymph nodes and/or skeleton, and/or central nervous system, and/or peripheral nervous system and/or lung.
One implementation of amethod4900 according to this disclosure for removing an organ with the assistance of a TD is shown inFIG.49. In some implementations, organ(s) may be removed from a donor to surgically implant into a recipient patient. In some implementations, organ(s) may be removed for disease and pathologic analysis. In some implementations, the donor may be the recipient patient (for example, a muscle graft). Althoughmethod4900 is shown in the figure beginning withstep4931, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod4900 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.49.
Step4931 may comprise using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the target tissue and/or organ(s) and/or the surrounding tissue(s).Step4931 may be performed using, for example, needles, sutures, hooks, clamps, retractors, probes, bars, endoscopes, rakes, tubes, TD and/or by hand. In some implementations,step4931 may be performed concurrently withstep4932.Step4932 may comprise passing the TD to at least substantially free the organ(s) from the surrounding tissues. In some implementations,step4932 may further comprise applying energy to the tissues during this TD passage.Step4933 may comprise testing the target tissue and/or organ to determine if it has been sufficiently freed from the surrounding tissues for uncomplicated removal. In some implementations endoscopes and/or blunt probes and/or TD may be passed around the target organ/tissue to determine the degree of freedom a target tissue and/or organ has from its surrounding tissues and/or organs.Step4934 may comprise (if further freeing appears necessary) using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the target tissue and/or organ and/or the surrounding tissue while the TD may be passed to further free the target tissue and/or organ; energy may be applied during this TD passage.Step4935 may comprise passing the TD (after the target tissue and/or organ has been removed) to the tissues that were adjacent and remaining in the body, which may aid the surgeon in examining for points of further bleeding and/or for further exploration; during such passage energy may be applied to the lysing member(s) (in order to attempt hemostasis and/or induce postoperative fibrosis). In some implementations, traditional instruments may be used to achieve hemostasis.Step4936 may comprise clamping and/or sealing critical ducts and/or blood vessels on the target tissue and/or organ so that the target tissue and/or organ may be properly transferred to and/or transported to and/or stored for the recipient patient if it is a donor organ. In some implementations, an organ may be cooled or refrigerated. In other implementations if the target tissue and/or organ is diseased, the tissue may be properly placed in the appropriate medium for a pathologist to examine or test. In some implementations, one or more of these steps using the TD may be performed with a fanning motion. In implementations using TD's with axially oriented protrusions, such a fanning motion may comprise a to and fro spokewheel pattern. In implementations using TD's with at least one nonaxially oriented protrusion, such a fanning motion may comprise a side-to-side fanning motion; one example of a fanning motion using a TD having at least one nonaxially oriented protrusion may comprise a ‘windshield wiper’ motion. In some implementations, organs and/or organ systems that the TD may be useful to remove may include but not limited to skin, and/or fibrous tissues, and/or muscle, and/or parotid, and/or salivary gland, and/or thyroid, and/or breast, and/or lung, and/or heart, and/or gastrointestinal, and/or liver, and/or pancreas, and/or spleen, and/or gallbladder, and/or kidney, and/or adrenal, and/or prostate, and/or ovary, and/or uterus, and/or bladder, and/or vascular, and/or lymph nodes and/or skeleton, and/or central nervous system, and/or peripheral nervous system.
One implementation of amethod5000 according to this disclosure for removing and/or freeing target scar tissue and/or fibrosis (or another fibrous tissue) from an organ with the assistance of a TD is shown inFIG.50. Althoughmethod5000 is shown in the figure beginning withstep5031, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod5000 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.50.
Step5031 may comprise using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the scar tissue and/or fibrous tissue and/or the surrounding tissue(s).Step5031 may be performed using, for example, needles, sutures, hooks, clamps, retractors, probes, bars, endoscopes, rakes, tubes, TD and/or by hand. In some implementations step5031 may be performed concurrently withstep5032.Step5032 may comprise passing the TD to at least substantially free the scar tissue and/or other fibrous tissue from the surrounding tissues. In some implementations,step5032 may further comprise applying energy to the lysing member during this TD passage.Step5033 may comprise identifying and/or testing the scar tissue and/or other fibrous tissue to determine if it has been sufficiently freed from the surrounding tissues and/or organ for uncomplicated removal. In some implementations endoscopes and/or blunt probes and/or TD and/or surgeon's hands may be passed around the scar tissue and/or other fibrous tissue to test the degree of freedom the scar tissue and/or other fibrous tissue has from the surrounding tissues and/or organs (in order to attempt hemostasis and/or modulate postoperative fibrosis).Step5034 may comprise (if further freeing appears necessary) using additional instrumentation to put force upon and/or pull and/or stretch and/or make taught the scar tissue and/or other fibrous tissue and/or the surrounding tissue and/or organ while the TD may be passed to further free the target scar tissue and/or other fibrous tissue; energy may be applied to the lysing member during this TD passage.Step5034 may be repeated as necessary until the target scar tissue and/or other fibrous tissue is sufficiently freed and/or removed.Step5035 may comprise passing the TD (after the target scar tissue and/or fibrosis has been removed) to the tissues that were adjacent to the removed tissues (and still remaining in the body), which may aid the surgeon in examining for points of further bleeding and/or for further exploration; during such TD passage, energy may be applied to the tissues via the lysing member(s) and/or the energy window(s).Step5036 may comprise using the TD to subdivide portions of the scar tissue and/or other fibrous tissue which may aid in extracting the scar tissue and/or other fibrous tissue in pieces if the surgery is done via a minimally invasive technique. In some implementations, if the surgical incision in the body is larger, the scar tissue and/or other fibrous tissue may pass more freely out of the body without piecemeal removal. In some implementations, one or more of these steps using the TD may be performed with a fanning motion. In implementations using TD's with axially oriented protrusions, such a fanning motion may comprise a to and fro spokewheel pattern. In implementations using TD's with at least one nonaxially oriented protrusion, such a fanning motion may comprise a side-to-side fanning motion; one example of a fanning motion using a TD having at least one nonaxially oriented protrusion may comprise a ‘windshield wiper’ motion. In some implementations, organs and/or organ systems that the TD may be useful to free and/or remove scar tissue and/or other fibrous tissue from may include but not limited to muscle, and/or parotid, and/or salivary gland, and/or thyroid, and/or lung, and/or heart (pericardial adhesions), and/or gastrointestinal (strictures), and/or liver, and/or pancreas, and/or spleen, and/or gallbladder (adhesions), and/or kidney, and/or adrenal, and/or prostate, and/or ovary, and/or uterus, and/or bladder, and/or vascular, and/or lymph nodes and/or skeleton, and/or central nervous system, and/or peripheral nervous system and/or lung (pleural adhesions) and/or fat (fibrous bands of cellulite). In some implementations, scarred and/or other fibrous tissue may bleed more than normal tissues when acted upon by a standard scalpel and/or surgical scissors; the TD may aid in such scarred and/or fibrotic tissue removal as the TD may be able to coagulate synchronously with both blunt and sharp dissection capabilities. The TD lysing member(s) may be able to contact more small bleeding vessels (than a non-planar surgical device) due to TD's planar geometry and the chance that the geometry of the bleeding tissues may be substantially planar.
An implementation of amethod5100 for incapacitating apocrine glands is shown inFIG.51. Althoughmethod5100 is shown in the figure beginning withstep5105, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod5100 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.51.
Step5105 may comprise: having the surgical area cleaned by, for example, isopropyl alcohol (degreaser) followed by germicidal chlorhexidine scrub.Step5110 may comprise: applying a local anesthetic (such as injecting), such as about 1 cc of a 1% lidocaine+1:10,000 adrenaline, to form about a wheal/hive on the periphery of the proposed dissection area on the axilla.Step5115 may comprise, after allowing the local anesthetic to settle, making an entrance incision and creating a tip deployment pocket. The first sub-step ofstep5115 may comprise, after allowing the local anesthetic to settle, performing a simple “stab” incision of the wheal, for example, a #15 Bard-Parker™ Scalpel into the subcutaneous fat. This incision may be about 3 mm in length or less. The second sub-step ofstep5115 may comprise creating a tip deployment pocket that may receive the lysing tip; said pocket may be made using a scalpel, scissors and/or wide array of instruments known in the art to dissect tissue. The tip deployment pocket may be made by blunt dissection such as using a Metzenbaum scissors in a spreading fashion and/or by sharp dissection using scalpel blade and/or scissor and/or energized dissection (for example, by laser and/or electrosurgical needle and/or ultrasonic probe); bleeding points may be coagulated in the standard methods. In certain implementations, a comfortable size of the tip deployment pocket may be about 150% of the length of the lysing tip with a comfortable range of 100% to 300% of length of the lysing tip. For example, a 13 mm lysing tip may deploy to the treatment configuration in a pocket of 2 cm squared or a circular pocket of 2 cm in diameter. In alternative implementations, the surgeon may open an additional incision down the path closer to the treatment zone.
Step5120 may comprise: applying one or more fluids to the tissue. In some implementations, the fluid(s) may comprise water. In some implementations, the fluid(s) may comprise an ionic fluid, such as a saline solution. The fluid(s) may be applied to the tissue by, for example, injection into the stab wound(s) and may comprise a fluid that is both ionic and an anesthetic, such as a tumescent anesthesia. Some implementations may comprise applying one or more fluids that serve as an ionic fluid, an anesthetic, and an adrenaline In some such implementations, the fluid(s) may comprise a Klein Formula, such as about 1 cc-3 cc of Klein Formula (such as a 0.1% lidocaine+epinephrine 1:1,000,000+NaHCO3@5 meq/L of saline) per square centimeter of anticipated dissection. This fluid(s) may be injected into the stab wounds via, for example, a 3 mm spatula cannula with syringe, and may be fanned out to match the area to be dissected/undermined. In some implementations, Tumescent Anesthesia (TA) may be allowed to settle for about 10-30 minutes.
One or more fluids may alternatively, or additionally, be applied to the tissue by using the TD. For example, the TD may comprise one or more canals for delivering fluids to the tissue (for example,canal304 depicted inFIG.3a). In some embodiments, the canal(s) may be configured to deliver the fluid(s) adjacent to the lysing tip such as via a port located adjacent to the internal device cannula and/or lysing tip. In some such embodiments, the canal(s) may be configured to deliver the fluid(s) to the area around the lysing tip.
In some implementations, heat may be produced or energy may otherwise be released in the dermis or subdermis as the TD is passed in a subdermal plane. Heat or energy from below may heat the dermis. In some implementations, heating portions of the dermis such as upper dermis or attached epidermis may be undesirable. As such, in some implementations, undesirable heating of such layers may be mitigated as described in theprevious method5100 for apocrine glands.
In some implementations, heat may be produced or energy may otherwise be released in the dermis or subdermis as the TD is passed in a subdermal plane. Heat or energy from below may heat the dermis. In some implementations, heating portions of the dermis such as upper dermis or attached epidermis may be undesirable. As such, in some implementations, undesirable heating of such layers may be mitigated by a applying a cooling step antecedent and or concurrent to energy delivery with the TD. Such steps may comprise use of a cooling mechanism such as a cooling mechanism comprising a contact cooling object such as a cooling pad or bag. Such cooling mechanism may comprise for example, a closed water bag at a temperature of less than 37° C. In some implementations, the fluid or gel may range in temperature of between 1° C. to 20° C. In some such implementations, the fluid or gel may be about 15° C. Other cooling mechanisms may comprise a dynamic cooling system wherein a cool liquid and/or gel and/or gas is actively pumped into or though the contact cooling object. In other implementations, a thermoelectric or Peltier cooling mechanism may be applied to externally cool the skin. One or more cooling fluids (which may include gasses and/or gels) may alternatively, or additionally, be applied to the tissue by using the TD. For example, the TD may comprise one or more canals for delivering fluids such as coolants to the tissue. In some embodiments, the canal(s) may be configured to deliver the fluid(s) adjacent to the lysing tip such as via a port located adjacent to the internal device cannula and/or lysing tip.
Step5130 may comprise: inserting TD into the incision and fanning in strokes sufficient to cover a target area of for example, about 60 sqcm.
Step5135 may comprise applying energy to one or more portions of the dissected area, for example, to heat the tissue to a desired temperature to cause a desired effect, for example, to alter sweat glands and/or nerves and/or the tissues surrounding said glands or nerves. In some implementations, such energy may be applied through the lysing tip by activating the electrosurgical generator's coagulation mode. In alternative embodiments, the lysing tip may be replaced with a tissue modifying tip (TMT) illustrated inFIGS.32 and33 which may be activated with coagulation energy. In alternative implementations, a surgeon may choose another method to apply energy to tissues. Applying cooling fluids and/or cooling methods during this step may be beneficial.
Step5137 may comprise: milking the dissected area to determine if any significant bleeding or drainage is present.
Step5140 may comprise closing the entrance wounds or surface incisions via glues, staples, adhesive skin closure strips, and/or sutures.
TD may be used in an implementation of amethod5200 for incapacitating eccrine glands as shown inFIG.52. Althoughmethod5200 is shown in the figure beginning withstep5205, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod5200 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.52.
Step5205 may comprise: having the surgical area cleaned by, for example, isopropyl alcohol (degreaser) followed by germicidal chlorhexidine scrub.Step5210 may comprise: applying a local anesthetic (such as injecting), such as about 1 cc of a 1% lidocaine+1:10,000 adrenaline, to form a wheal/hive on the periphery of the proposed dissection area on the axilla.Step5215 may comprise, after allowing the local anesthetic to settle, making an entrance incision and creating a tip deployment pocket. The first sub-step ofstep5215 may comprise, after allowing the local anesthetic to settle, performing a simple “stab” incision of the wheal, for example, a #15 Bard-Parker™ Scalpel into the subcutaneous fat. This incision may be about 3 mm in length or less. The second sub-step ofstep5215 may comprise creating a tip deployment pocket that may receive the lysing tip; said pocket may be made using a scalpel, scissors and/or wide array of instruments known in the art to dissect tissue. The tip deployment pocket may be made by blunt dissection such as using a Metzenbaum scissors in a spreading fashion and/or by sharp dissection using scalpel blade and/or scissor and/or energized dissection (for example, by laser and/or electrosurgical needle and/or ultrasonic probe); bleeding points may be coagulated in the standard methods. In certain implementations, a comfortable size of the tip deployment pocket may be about 150% of the length of the lysing tip with a comfortable range of 100% to 300% of length of the lysing tip. For example, a 13 mm lysing tip may deploy to the treatment configuration in a pocket of 2 cm squared or a circular pocket of 2 cm in diameter.
Step5220 may comprise: applying one or more fluids to the tissue. In some implementations, the fluid(s) may comprise water. In some implementations, the fluid(s) may comprise an ionic fluid, such as a saline solution. The fluid(s) may be applied to the tissue by, for example, injection into the stab wound(s) and may comprise a fluid that is both ionic and an anesthetic, such as a tumescent anesthesia. Some implementations may comprise applying one or more fluids that serve as an ionic fluid, an anesthetic, and an adrenaline In some such implementations, the fluid(s) may comprise a Klein Formula, such as about 1 cc-3 cc of Klein Formula (such as a 0.1% lidocaine+epinephrine 1:1,000,000+NaHCO3@5 meq/L of saline) per square centimeter of anticipated dissection. This fluid(s) may be injected into the stab wounds via, for example, a 3 mm spatula cannula with syringe, and may be fanned out to match the area to be dissected/undermined. In some implementations, Tumescent Anesthesia (TA) may be allowed to settle for about 10-30 minutes.
One or more fluids may alternatively, or additionally, be applied to the tissue by using syringes and/or other cannulas and/or tubing. Alternatively, the TD may comprise one or more canals for delivering fluids to the tissue. In some embodiments, the canal(s) may be configured to deliver the fluid(s) adjacent to the lysing tip such as via a port located adjacent to the internal device cannula and/or lysing tip. In some such embodiments, the canal(s) may be configured to deliver the fluid(s) to the area around the lysing tip.
In some implementations, heat may be produced or energy may otherwise be released in the dermis or subdermis as the TD is passed in a subdermal plane. Heat or energy from below may heat the dermis. In some implementations, heating portions of the dermis such as upper dermis or attached epidermis may be undesirable. As such, in some implementations, undesirable heating of such layers may be mitigated as described in theprevious method5000 for apocrine glands.
Step5230 may comprise: inserting TD into the incision and fanning in strokes sufficient to cover a target area of for example, about 60 sqcm.
Step5235 may comprise applying energy to one or more portions of the dissected area, for example, to heat the tissue to a desired temperature to cause a desired effect, for example, to alter sweat glands and/or nerves and/or the tissues surrounding said glands or nerves. In some implementations, such energy may be applied through the lysing tip by activating the electrosurgical generator's coagulation mode. In alternative embodiments, the lysing tip may be replaced with a tissue modifying tip (TMT) illustrated inFIGS.32 and33 which may be activated with coagulation energy. In alternative implementations, a surgeon may choose another method to apply energy to tissues. Applying cooling fluids and/or cooling methods during this step may be beneficial.
Step5237 may comprise: milking the dissected area to determine if any significant bleeding or drainage is present.
Step5240 may comprise closing the entrance wounds or surface incisions via glues, staples, adhesive skin closure strips, and/or sutures.
TD may be used in one implementation of amethod5300 for incapacitating hair follicles is shown inFIG.53. Althoughmethod5300 is shown in the figure beginning withstep5305, it should be understood that any of the preliminary and later steps described above in connection with other implementations and/or methods and/ormethods4000,4100, and4200 may be performed inmethod5300 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.53.
Step5305 may comprise: having the surgical area cleaned by, for example, isopropyl alcohol (degreaser) followed by germicidal chlorhexidine scrub.Step5310 may comprise: applying a local anesthetic (such as injecting), such as about 1 cc of a 1% lidocaine+1:10,000 adrenaline, to form about a wheal/hive on the periphery of the proposed dissection area.
Step5315 may comprise, after allowing the local anesthetic to settle, making an entrance incision and creating a tip deployment pocket. The first sub-step ofstep5315 may comprise, after allowing the local anesthetic to settle, performing a simple “stab” incision of the wheal, for example, a #15 Bard-Parker™ Scalpel into the subcutaneous fat. This incision may be about 3 mm in length or less. The second sub-step ofstep5315 may comprise creating a tip deployment pocket that may receive the lysing tip; said pocket may be made using a scalpel, scissors and/or wide array of instruments known in the art to dissect tissue. The tip deployment pocket may be made by blunt dissection such as using a Metzenbaum scissors in a spreading fashion and/or by sharp dissection using scalpel blade and/or scissor and/or energized dissection (for example, by laser and/or electrosurgical needle and/or ultrasonic probe); bleeding points may be coagulated in the standard methods. In certain implementations, a comfortable size of the tip deployment pocket may be about 150% of the length of the lysing tip with a comfortable range of 100% to 300% of length of the lysing tip. For example, a 13 mm lysing tip may deploy to the treatment configuration in a pocket of 2 cm squared or a circular pocket of 2 cm in diameter. In alternative implementations, the surgeon may open an additional incision down the path closer to the treatment zone.
Step5320 may comprise: applying one or more fluids to the tissue. In some implementations, the fluid(s) may comprise water. In some implementations, the fluid(s) may comprise an ionic fluid, such as a saline solution. The fluid(s) may be applied to the tissue by, for example, injection into the stab wound(s) and may comprise a fluid that is both ionic and an anesthetic, such as a tumescent anesthesia. Some implementations may comprise applying one or more fluids that serve as an ionic fluid, an anesthetic, and an adrenaline In some such implementations, the fluid(s) may comprise a Klein Formula, such as about 1 cc-3 cc of Klein Formula (such as a 0.1% lidocaine+epinephrine 1:1,000,000+NaHCO3@5 meq/L of saline) per square centimeter of anticipated dissection. This fluid(s) may be injected into the stab wounds via, for example, a 3 mm spatula cannula with syringe, and may be fanned out to match the area to be dissected/undermined. In some implementations, Tumescent Anesthesia (TA) may be allowed to settle for about 10-30 minutes.
One or more fluids may alternatively, or additionally, be applied to the tissue by using the TD. For example, the TD may comprise one or more canals for delivering fluids to the tissue. In some embodiments, the canal(s) may be configured to deliver the fluid(s) adjacent to the lysing tip such as via a port located adjacent to the internal device cannula and/or lysing tip. In some such embodiments, the canal(s) may be configured to deliver the fluid(s) to the area around the lysing tip. Alternatively, or additionally, the fluid(s) may be delivered elsewhere on the tip or elsewhere on the shaft of the TD.
In some implementations, heat may be produced or energy may otherwise be released in the dermis or subdermis as the TD is passed in a subdermal plane. Heat or energy from below may heat the dermis. In some implementations, heating portions of the dermis such as upper dermis or attached epidermis may be undesirable. As such, in some implementations, undesirable heating of such layers may be mitigated as described in theprevious method5000 for apocrine glands.
Step5330 may comprise: inserting TD into the incision and fanning in strokes sufficient to cover an area of for example, about 60 sqcm.
Step5335 may comprise applying energy to one or more portions of the dissected area, for example, to heat the tissue to a desired temperature to cause a desired effect, for example, to alter hair follicles and/or the tissues surrounding said follicles. In some implementations, such energy may be applied through the lysing tip by activating the electrosurgical generator's coagulation mode. In alternative embodiments, the lysing tip may be replaced with a tissue modifying tip (TMT) illustrated inFIGS.32 and33 which may be activated with coagulation energy. In alternative implementations, a surgeon may choose another method to apply energy to tissues. Applying cooling fluids and/or cooling methods during this step may be beneficial.
Step5337 may comprise: milking the dissected area to determine if any significant bleeding or drainage is present.
Step5340 may comprise closing the entrance wounds or surface incisions via glues, staples, adhesive skin closure strips, and/or sutures.
In one implementation, TD may be used for the treatment of cellulite, such ascellulite treatment zones5401 and5402 as shown inFIG.54. Said implementation may comprise amethod5500 of steps listed inFIG.55. A more particular example of such an implementation is further illustrated inFIG.54. It should be understood that any of the steps described above in connection with other implementations and/ormethods4000,4100, and4200 may be performed inmethods5500 as well. For example, one or more other steps of any of the other implementations described herein such as for example, steps4005-4035 of the method depicted inFIG.40, steps4105-4115 of the method depicted inFIG.41, and steps4205-4240 of the method depicted inFIG.42 may also be included in the method depicted inFIG.55.
Step5505 comprises making an entrance incision. In some implementations step5505 may comprises making astab incision5410 in a location that is not usually visible to the eye, for example, the bikini line. In some implementations the incision may be of sufficient length to receive the lysing tip and/or cannula in an axial/delivery configuration. Preferably, the length of the incision is no greater than as necessary to receive the lysing tip and/or cannula. Preferably, the length of the incision is smaller than the length of the lysing tip in its treatment configuration. In some implementations, the length of the incision may be between about 2 mm and 12 mm.
Step5510 may comprise forming atip deployment pocket5411afor receipt and/or reconfiguring of the lysing tip from its delivery configuration to its treatment configuration. In some implementations, curved blunt scissors may be used to make this tip deployment pocket by for example inserting said scissors up to its pivot point and/or opening/closing the scissors. In some implementations, the tip deployment pocket may be approximately the size of half of a postage stamp. For example, the tip deployment pocket may have a width in the direction of the incision of about 1 cm. Similarly, the tip deployment pocket may have a length perpendicular to the width of between about 1 cm to 2 cm. The dissection plane of the pocket is preferably in the same plane of dissection of the path to the treatment zone and/or the treatment zone. However, it is contemplated that in an alternative implementation a surgeon may use the TD to move from the plane of the pocket into another tissue plane. Preferably, the width of the tip deployment pocket is larger than the length of the incision to, for example, minimize scarring but create an area large enough to accommodate the lysing tip being deployed to its treatment configuration. Preferably, the width of the tip deployment pocket is approximately equal to or slightly larger than the length of the lysing tip. In some implementations, the proximal edge of the tip deployment pocket defining the width of the pocket may be coincident with or positioned slightly distal of the incision line as shown inFIG.54a. The tip deployment pocket may be made using a scalpel, scissors, and/or wide array of instruments known in the art to dissect tissue. In certain implementations, a comfortable size of the tip deployment pocket may be about 150% of the length of the lysing tip with a comfortable range of 100% to 300% of length of the lysing tip. For example, a 13 mm lysing tip may deploy to the treatment configuration in a pocket of 2 cm squared or a circular pocket of 2 cm in diameter. In alternative implementations, the surgeon may open an additional incision down the path closer to the treatment zone.
Step5515 may comprise inserting the TD through the incision and deploying/securing the lysing tip. In some implementations, the TD may be deployed through a cannula and once within the tip deployment pocket may be reconfigured from its delivery configuration to its treatment configuration. In other implementations, the lysing tip and/or grasping/control means may be inserted through the incision to the tip deployment pocket in which the lysing tip and grasping/control means may be coupled together in the treatment configuration. For example, the lysing tip may be grasped in an axial configuration such as along one of the sides of thegrasping pad718 as shown inFIG.7e. The lysing tip may then be released and rotated manually, such as by palpation, after which the lysing tip may be grasped in the treatment configuration with the elongated length of the lysing tip perpendicular or at least substantially perpendicular to the axis of the grasping/control. means.
In some implementations in which the lysing tip, either lysingtip710 or any of the other free floating lysing tips disclosed herein, are manually inserted, a surgeon may insert the lysing tip through an entrance incision such that the longest axis of the lysing tip (typically the axis between the two outer protrusions and/or beads) is parallel or at least substantially parallel to the direction of insertion. Once the lysing tip has been inserted through the entrance incision, the lysing tip may be manually rotated such as by palpation, or by use of the control/grasping instrument, or an external device such as a hemostat or another suitable instrument. In some such implementations, a tip deployment pocket may be created before insertion of the lysing tip as discussed below. This tip deployment pocket may facilitate rotation of the lysing tip and/or may allow for coupling of the lysing tip with a suitable instrument for delivering electrosurgical energy and/or controlling the lysing tip during a surgical procedure.
Step5516 may comprise having in place and utilizing an infrared and/or heat detecting camera13 (e.g., FLIR®) connected by wire or wirelessly (for example viaantennae47a) to acentral processing unit14 andoutput video monitor15; the camera data may be combined with data input that may be generated by signals originating from RFID chips and/orantennae47 with further data that may originate fromsensors48 that may be located on or near lysing tips or TMTs (lysing tip and control graspinginstrument system16 are depicted inFIG.54awithantennae47 andsensor48 mounted on grasping control instrument shaft). In some embodiments,sensor48 may be a thermistor. Infrared camera images overlying sensor outputs and location outputs on the video screen may aid the surgeon in determining the proper speed of the tip and/or settings and/or dwelling time. One or more of these steps involving use of an infrared camera may be applied to other ski-related methods disclosed herein such as those related to treatment of apocrine and eccrine sweating, incapacitation of hair follicles, treatment of cellulite, wrinkles, lines, folds, and other defects, as well as rejuvenational treatments for the face, neck, and brow/scalp.
Step5520 may comprise forming one ormore paths5412a/5412bto one ormore treatment zones5401 and/or5402 respectively. In some implementations, a fifth step may comprise activating one or more lysing members and then advancing the lysing tip towards the treatment zone. This may be done for example in a series of substeps by advancing the lysing tip and pulling it back in a repeated fashion similar to a battering ram. The surgeon may create additional paths adjacent to the initial path, thus creating a triangular and/or cone shape between the incision and the treatment zone. In alternative implementations, wherein the surgeon may prefer to minimize the amount of energy deposited along the path to the target tissue/cellulite treatment zone, especially while using lysing tips of 3 protrusions or less, the lysing tip may be rotated with the lysing rod axis perpendicular to the plane of the skin to create the path. Rotating the lysing rod axis perpendicular may allow the tip to migrate in between the vertically oriented fibrous bands between the dermis and the lower/deeper tissues. As shown inFIG.54a, if thetreatment zone5401 has a width wider than the width of the path, the surgeon may, either right before or simultaneously with movement of the tip into the treatment zone, manipulate the treatment zone, such as by traction (either manual or using instrumentation), into the path of the lysing tip. For example, as indicated byarrow5415, initially a top portion of the treatment zone may be forced downward into the path of the lysing tip. The lysing tip may then be used to treat the top portion of the treatment zone. Subsequently, a bottom portion of the treatment zone may then be manipulated in the direction ofarrow5416 into the path of the lysing tip and the lysing tip may then be used to treat the bottom portion of the treatment zone. In some implementations, the lysing tip will extend beyond the boundaries of thetreatment zone5401; this “feathering” beyond the boundaries into more normal tissues may ensure full treatment of the condition. This step may be repeated to treat all of the various treatment zones such as5402. Preferably, paths to each of the various treatment zones (for example,5412b) may come from thesame incision5410 and tip deployment pocket5411.
In an alternative implementation depicted inFIG.54b, thetip deployment pocket5411bmay be more adjacent to thetreatment zone5401. In some such implementations thetip deployment pocket5411bmay be formed during the course of repositioning the lysing tip between its delivery and treatment configurations. For example, the proximal portion of thepath5413 may be formed by advancing the cannula and/or lysing tip from the incision in the delivery configuration after which the lysing members may be activated and the lysing tip rotated or otherwise repositioned from the delivery to the treatment configurations thereby forming a tip delivery pocket for delivery of the lysing tip to the treatment zone.
Step5525 may comprise, after lysing the tissues in the treatment zone, applying energy to the treatment zone. In some implementations, energizing the lysing member(s) with a cut and/or coagulation and/or blend between cut and coagulation energy waveforms may accomplish a desired treatment, for example, heating/denaturing the subcutaneous adipose tissues which may result in their reduction and/or heating the subdermal tissue layers to cause a skin tightening effect. In other implementations, to apply energy to the treatment zone(s), the lysing tip may be withdrawn from the incision and another energy deposition device and/or a TMT (Tissue Modification Tip) may be energized to deposit energy in the treatment zone(s) for an intended effect. The TMT may be passed to or through the treatment zone with the energy window facing upwards towards the subdermal layers. Possible results of pointing upwards may include alteration of the collagen in that area yielding overlying skin tightening. In some implementations, the TMT may be turned upside down with the energy window directed at the subcutaneous adipose tissue layer and energized during at least part of the procedure. Possible results of this may include the alteration and/or damaging and/or death of some adipose cells that stimulate an inflammatory response in the subcutaneous adipose tissues that may transfer to the subdermal and/or dermal layers via cells and/or chemical/biological mediators thus possibly resulting in the alteration of tissue thickness and/or tissue tightening in tissues that had not been directly damaged/modified by the lysing tip and/or TMT.
In some implementations, a surgeon may reduce bleeding by use of such instruments as a bovie probe and/or grasper/clamp. In alternative implementations, the surgeon may use the lysing members of the lysing tip and/or the energy window of the TMT to modify tissues for various intended results, including but not limited to skin tightening and fat modification. In such implementations, the energy window of the TMT may be configured to deliver the following types of energy modalities including but not limited to laser, intense pulse light, resistive heating, radiant heat, thermochromic, ultrasound, and/or microwave.
Step5530 may comprise rotating and/or reconfiguring the lysing tip back into the delivery configuration in either the treatment area and/or the tip deployment pocket and/or the path, if it is sufficiently wide, and withdrawing the lysing tip and/or cannula back through the incision.
An example of amethod5600 for face dissection and/or face lifting according to some implementations will now be described as illustrated inFIG.56.
Step5605 may comprise, after allowing the local anesthetic to settle, making and/or extending and/or using an existing entrance incision at the front/bottom/rear of the ear and creating a tip deployment pocket. However, incisions with endoscopic and/or laparoscopic instruments should not be limited to this area as cosmetic surgeons may prefer to place incisions at anatomical boundaries and/or natural crease areas. In further contemplated embodiments, intra-oral, intra-nasal, and routes of instrument passage through the inner eyelids may be used for device and/or tip delivery. For example, an incision may be made where the nose and lip meet the cheek. An incision may be made in the skin in such a selected area so as to introduce a laparoscopic/endoscopic instrument, scissors, and/or scalpel to create a tip deployment pocket adjacent the incision if desired. The first sub-step ofstep5605 may comprise, after allowing the local anesthetic to settle, performing a simple “stab” incision of the wheal, for example, a #15 Bard-Parker™ Scalpel into the subcutaneous fat. This incision may be about 3 mm in length or less. The second sub-step ofstep5605 may comprise creating a tip deployment pocket that may receive the lysing tip which may be positioned at the distal end of the device, which pocket may be made/enlarged with a scalpel, any laparoscopic instrument with or without electrosurgical current applied to it, an ultrasonic surgical device and/or microwave-powered instrument and/or laparoscopic scissors, and/or thermochromic media, electromagnetically energized instrument, and/or thermally energized instrument, and/or scissor tips, and/or knife tips. The tip deployment pocket may be made by blunt dissection such as using a Metzenbaum scissors in a spreading fashion and/or by sharp dissection using scalpel blade and/or scissor and/or energized dissection (for example, by laser and/or electrosurgical needle and/or ultrasonic probe); bleeding points may be coagulated in the standard methods. In certain implementations, a comfortable size of the tip deployment pocket may be about 150% of the length of the lysing tip with a comfortable range of 100% to 300% of length of the lysing tip. For example, a 13 mm lysing tip may deploy to the treatment configuration in a pocket of 2 cm squared or a circular pocket of 2 cm in diameter. The tip deployment pocket may or may not be the desired tissue layer of the dissection and/or the final dissection as various blends of dissection planes may be used by certain surgeons to achieve desired face lifting. However, a comfortable plane in which to create a tip deployment pocket would likely be the upper subcutaneous plane in the preauricular region. Tip deployment pockets may be created in other locations using endoscopic instruments farther along the planned path of dissection and/or via separate stab incision further along the path of dissection. The instrument that made the tip deployment pocket is then removed. Depending upon the quality of the tissue in the tip deployment pocket adjacent the entrance incision, the lysing tip of the TD may be used to form the tip deployment pocket by energizing the lysing members of the lysing tip while rotating the lysing tip from the delivery configuration to the treatment configuration.
Step5610 may comprise inserting the TD through the incision into the tip deployment pocket for receipt and/or reconfiguring of the lysing tip from its delivery configuration to its treatment configuration.
In some implementations, the TD may be deployed through a cannula and once within the tip deployment pocket may be reconfigured from its delivery configuration to its treatment configuration. In other implementations, the lysing tip and/or grasping/control means may be inserted through the incision to the tip deployment pocket in which the lysing tip and grasping/control means may be coupled together in the treatment configuration. For example, the lysing tip may be grasped in an axial configuration such as along one of the sides of thegrasping pad718 as shown inFIG.7eprior to inserting the TD in the incision. The lysing tip may then be inserted in the incision and released. Then the lysing tip may be rotated; if necessary, manual rotation may be implemented (for example, by palpation) after which the lysing tip may be grasped in the treatment configuration with the elongated length of the lysing tip perpendicular or at least substantially perpendicular to the axis of the grasping/control means.
Step5615 may comprise making paths with the TD. In some implementations, after activating the TD, the surgeon may advance the tip a certain distance, for example, 2 cm. The tip may then be pulled back (with or without electrosurgical energy), in some cases to the tip deployment pocket, and dissection may then proceed along the same path or along an immediately adjacent path. It may be convenient for the surgeon to only partially overlap advancing strokes especially in more dense tissue. It may also be beneficial not to use energy on the withdrawal (non-forward) portion of the strokes. A possible example of only partially overlapping advancing strokes is, if the device is four bulbs wide (the initial path should be about four bulbs wide); a new adjacent path may be lysed with two bulbs in the new adjacent path and two bulbs in the previously dissected path. The device tip may then be pulled back, in some cases to the tip deployment pocket, and advanced on the other adjacent path immediately adjacent to the original dissection path with two bulbs in the new adjacent path and two bulbs in the original dissection path. If using the four bulb device example, the width of the original dissection would be four bulbs. Then the additional adjacent dissection paths would be two plus two bulbs in width resulting in an overall two plus two plus two equal six bulb width path after three forward strokes. The device path may be lengthened in segments in a similar fashion. The device path width may be increased in segments in a similar fashion.
The dissection may be increased segmentally until it occupies the entire area the surgeon desires to dissect at the appropriate depth or plane(s) of choice of the surgeon. Other endoscopic instruments may be used to observe and/or maintain the plane and/or address bleeding blood vessels and/or tissues. Upon completion of the desired dissection, within any point of the dissection with sufficient area, the lysing tip may be rotated from the treatment configuration to the delivery configuration and withdrawn through the entrance incision.
Step5620 may comprise subjecting some or all exposed tissue(s) to additional energy via a lysing tip or a separate TMT. In some implementations, after dissection in segments and/or the total dissection, one or more additional types of energy may be applied to the inner and/or outer layers of the dissection plane. The lysing member of the TD and/or the energy window of the TMT may be directed at the subcutaneous adipose tissue layer and energized. Possible results of this may include the alteration and/or damaging and/or death of some adipose cells that stimulate an inflammatory response in the subcutaneous adipose tissues that may transfer to the subdermal and/or dermal layers via cells and/or chemical/biological mediators thus possibly resulting in the alternation of tissue thickness and/or tissue tightening in tissues that had not been directly damaged/modified by the lysing tip and/or TMT. In other implementations, energy applied to the inner layer of the dissection plane may alter and/or damage other tissues including fibrous tissues wherein the results of damaging said tissues may release mediators and/or products of damage such as charred debris which may also stimulate an inflammatory and/or immunologic response that may cause tissue contraction and/or fibrosis in that layer of the dissection plane and/or in an adjacent layer. In alternative implementations, the surgeon may use the lysing members of the lysing tip and/or the energy window of the TMT to modify tissues for various intended results, including but not limited to skin tightening and fat modification.
In some implementations, a surgeon may reduce bleeding by use of such instruments as a bovie probe and/or graspers or clamps and/or grasping and/or clamp-like instruments. In some implementations, a device utilizing ultrasonic vibration to cut and cauterize tissue such as a harmonic scalpel may be used to reduce bleeding. In alternative implementations, the surgeon may use the lysing members of the lysing tip and/or the energy window of the TMT to modify tissues for various intended results, including but not limited to skin tightening and/or fatty tissue modification. In such implementations, the energy window of the TMT may be configured to deliver the following types of energy: electrosurgical, ultrasound, intense pulse light, laser, radiant heat, thermochromic, and/or microwave. In such implementations, the energy window of the TMT may be configured to deliver the following types of energy modalities including, but not limited to, laser, intense pulse light, resistive heating, radiant heat, thermochromic, ultrasound, mechanical, and/or microwave.
Step5623 may comprise: lightly milking the dissected area to determine if any significant bleeding or drainage is present.
Step5624 may comprise closing the entrance wounds or surface incisions via glues, staples, adhesive skin closure strips, and/or sutures.
Step5625 may comprise post-operative care. Some post-operative dressings may be appropriate to reduce the incidence of seromas and/or hematomas. Appropriate dressings may include some with pressure characteristics. Incisions may be dealt with by methods that may include suturing and/or stapling and/or tissue gluing and/or taping, for example, with Steri-strips® and/or other methods that the surgeon may desire.
An example of amethod5700 for neck dissection and/or neck lifting according to some implementations will now be described as illustrated inFIG.57. This method may be performed by itself or with otherprocedures including method5600.
Step5705 may comprise, after allowing the local anesthetic to settle, making and/or extending and/or using an existing entrance incision and creating a tip deployment pocket. In some implementations, the neck dissection may be carried out by extending the lower portion of the face lift dissection or separately as its own procedure. Therefore, neck dissection entrance wounds may be located in the submental crease area and/or around the chin. Other entrance areas may also include those around the ear. However, incisions with endoscopic and/or laparoscopic instruments should not be limited to this area as cosmetic surgeons may prefer to place incisions at anatomical boundaries and/or natural crease areas. The first sub-step ofstep5705 may comprise, after allowing the local anesthetic to settle, performing a simple “stab” incision of the wheal, for example, a #15 Bard-Parker™ Scalpel into the subcutaneous fat. This incision may be about 3 mm in length or less. The second sub-step ofstep5705 may comprise creating a tip deployment pocket that may receive the lysing tip at the distal end of the device; the tip deployment pocket may be made using a scalpel, scissors, and/or wide array of instruments known in the art to dissect tissue. The tip deployment pocket may be made by blunt dissection such as using a Metzenbaum scissors in a spreading fashion and/or by sharp dissection using scalpel blade and/or scissor and/or energized dissection (for example, by laser and/or electrosurgical needle and/or ultrasonic probe); bleeding points may be coagulated in the standard methods. In certain implementations, a comfortable size of the tip deployment pocket may be about 150% of the length of the lysing tip with a comfortable range of 100% to 300% of length of the lysing tip. For example, a 13 mm lysing tip may deploy to the treatment configuration in a pocket of 2 cm squared or a circular pocket of 2 cm in diameter. The tip deployment pocket may or may not be the desired tissue layer of the dissection and/or the final dissection as various blends of dissection planes may be used by certain surgeons to achieve desired neck lifting. However, a comfortable plane in which to create a tip deployment pocket may be the upper subcutaneous plane in the preauricular region. Tip deployment pockets may be created in other locations using laparoscopic/endoscopic instruments farther along the planned path of dissection and/or via separate stab incision further along the path of dissection. The instrument that made the tip deployment pocket may then be removed. Depending upon the quality of the tissue in the tip deployment pocket adjacent the entrance incision, the lysing tip of the TD may be used to form the tip deployment pocket by energizing the lysing members of the lysing tip while rotating the lysing tip from the delivery configuration to the treatment configuration.
Step5710 may comprise forming a tip deployment pocket for receipt and/or reconfiguring of the lysing tip from its delivery configuration to its treatment
Step5715 may comprise making paths with the TD. In some implementations, after activating the TD, the surgeon may advance the tip a certain distance, for example, 2 cm. The tip may then be pulled back (with or without electrosurgical energy), in some cases to the tip deployment pocket, and dissection may then proceed along the same path or along an immediately adjacent path. It may be beneficial to reduce the amount of potential tissue damaging energy to use energy on advancing strokes of the TD and not using energy on the withdrawal (non-forward) portion of the strokes. For example, if the device is four bulbs wide, that is the width of the initial path. The new adjacent path may be lysed with two bulbs in the new adjacent path and two bulbs in the previously dissected path. The device tip may then be pulled back, in some cases to the tip deployment pocket, and advanced on the other adjacent path immediately adjacent to the original dissection path with two bulbs in the new adjacent path and two bulbs in the original dissection path. If using the four bulb device example, the width of the original dissection would be four bulbs. Then the additional adjacent dissection paths would be two plus two bulbs in width resulting in an overall two plus two plus two equal six bulb width path after three forward strokes. The device path may be lengthened in segments in a similar fashion. The device path width may be increased in segments in a similar fashion.
The dissection may be increased segmentally until it occupies the entire area the surgeon desires to dissect at the appropriate depth or plane(s) of choice of the surgeon. Other endoscopic instruments may be used to observe and/or maintain the plane and/or address bleeding blood vessels and/or tissues. Upon completion of the desired dissection, within any point of the dissection with sufficient area, the lysing tip may be rotated from the treatment configuration to the delivery configuration and withdrawn through the entrance incision.
Step5620 may comprise subjecting some or all exposed tissue(s) to additional energy via a lysing tip and/or a separate TMT. In some implementations, after dissection in segments and/or the total dissection, one or more additional types of energy may be applied to the inner and/or outer layers of the dissection plane. The lysing member of the TD and/or the energy window of the TMT may be directed at the subcutaneous adipose tissue layer and energized. Possible results of this may include the alteration and/or damaging and/or death of some adipose cells that stimulate an inflammatory response in the subcutaneous adipose tissues that may transfer to the subdermal and/or dermal layers via cells and/or chemical/biological mediators thus possibly resulting in the alternation of tissue thickness and/or tissue tightening in tissues that had not been directly damaged/modified by the lysing tip and/or TMT. In other implementations, energy applied to the inner layer of the dissection plane may alter and/or damage other tissues including fibrous tissues wherein the results of damaging said tissues may release mediators and/or products of damage such as charred debris which may also stimulate an inflammatory and/or immunologic response that may cause tissue contraction/tightening and/or fibrosis in that layer of the dissection plane and/or in an adjacent layer.
Step5623 may comprise lightly milking the dissected area to determine if any significant bleeding or drainage is present.
Step5624 may comprise closing the entrance wounds or surface incisions via glues, staples, adhesive skin closure strips, and/or sutures.
Step5625 may comprise, after the neck has been dissected, addressing such other concerns as platysmal banding and/or prolapsed tissues such as salivary glands using sutures and/or meshes and/or other laparoscopic/endoscopic tools as known in the art. In some implementations, a surgeon may reduce bleeding by use of such instruments as a bovie probe and/or graspers or clamps and/or grasping and/or clamp-like instruments. In some implementations, a device utilizing ultrasonic vibration to cut and cauterize tissue such as a harmonic scalpel may be used to reduce bleeding. In alternative implementations, the surgeon may use the lysing members of the lysing tip and/or the energy window of the TMT to modify tissues for various intended results, including but not limited to skin tightening and/or fatty tissue modification. In such implementations, the energy window of the TMT may be configured to deliver the following types of energy: electrosurgical, ultrasound, intense pulse light, laser, radiant heat, thermochromic, and/or microwave.
Step5630 may comprise post-operative care. Some post-operative dressings may be appropriate to reduce the incidence of seromas and/or hematomas. Appropriate dressings may include some with pressure characteristics. Incisions may be dealt with by methods that may include suturing and/or stapling and/or tissue gluing and/or taping, for example, with Steri-strips® and/or other methods that the surgeon may desire.
The TD may be used to treat various skin wrinkles, lines, folds and other visible defects. In an implementation, dissecting with the TD through, or around the platysma muscle in the neck in areas of lines or wrinkles may alter the attachments of the platysma to overlying or adjacent skin and thus diminish the visible assessment of surface defects.
In an alternative implementation, dissecting and/or energizing with the TD through or around the muscles of facial expression located in the superior nose, glabellar region, and/or adjacent tissues, for example, the procerus muscle, depressor supercilii muscle, and corrugator supercilii muscle may damage, denature, fibrose, alter, denervate and/or disconnect the muscles and their action from the overlying or adjacent skin thus reducing the frown wrinkles or folds around the superior nose.
In some implementations, the surface skin effects of other muscles of facial expression may be altered by dissecting the tissues which may be attached between those muscles and the surface skin, no matter how loosely or indirect, using the TD. For example, some muscles of facial expression around the mouth contribute to the formation of the nasal labial fold which gives may give an aging appearance depending upon its depth, acuteness, and/or shadow effect. Disinserting the surface skin in the area from the underlying or adjacent tissues by dissecting with the TD may diminish the visibility of these folds. The entrance incision for the TD to approach or reach the nasal labial fold may be anywhere on the face or head as well as inside the mouth or nose.
In another implementation, dissection with the TD may be used to diminish forehead wrinkles wherein the dissection and/or energy may damage, denature, fibrose, alter, denervate and/or disconnect the muscles and their action from the overlying or adjacent skin thus reducing the brow and/or forehead wrinkling.
In another implementation, the wrinkles around the lower and outer eyelids may be altered by dissecting between the orbicularis oculi muscle and the skin wherein a sheet of fibrous tissue may be laid down following dissection and/or energy which may have a less foldable character than the previously soft and pliable tissues. The entrance incision for the TD to approach the eyelid may be inside the lower eyelid through the conjunctiva and/or in a wrinkle of the face or lower eyelid.
Steps: everything for creating a path except can enter from inside nose or mouth or eye for areas mentioned above. Likely2 bulb unit used. Since wrinkle or fold, dissection will be along the length of or around the fold, not perpendicular to it. May be with or without energy. May use TMT after dissection is complete; may point up or down. May be used in conjunction with an implant, even an injectable, solid, semi-solid implant. Finally, withdraw and sew.
An example of amethod5800 for brow and/or scalp dissection and/or brow lifting according to some implementations will now be described as illustrated inFIG.58.Step5805 may comprise making a sufficient number of incisions at the back of neck near or at the hairline and/or forehead/frontal hairline that permits sufficient passage of TD for intended effect. In other implementations, incisions may be made anywhere within the scalp region.Step5810 may comprise creating the tip deployment pocket as disclosed herein.Step5810 may comprise forming a tip deployment pocket for receipt and/or reconfiguring of the lysing tip from its delivery configuration to its treatment.Step5815 may comprise dissecting the subgaleal plane with TD and may comprise fanning in the subgaleal plane, for example, in a spokewheel pattern, to the extent desired by the surgeon.Step5820 may comprise reconfiguring the TD from the treatment configuration to the delivery configuration and/or removal through the entrance incision.Step5825 may comprise, after desired tissue plane separation, rotating the dissected scalp in to the desired position, for example, backward toward neck.Step5830 may comprise applying a fixation mechanism, for example, screws.
An example of amethod5900 for creation of pockets for implants, including, but not limited to, cosmetic implants, medical device and identification implants is described. An implant may be defined herein as any material surgically deposited and left in a patient/recipient's body that was not manufactured by the recipient's body. The TD may be useful because it may expeditiously create said paths and said pockets with minimal bleeding. Examples of cosmetic implant procedures in which the TD may be used may include, but are not limited to, skin, breast, face (cheek, brow), muscle (biceps, triceps, calf), and buttocks implants, to name a few. Examples of medical device implants in which the TD may be used may include, but are not limited to, drug implant devices, for example, insulin infusion pumps, cardiac pacemakers, artificial joints, implantable neurologic devices, implantable tracking and/or identification (for example, RFID) chips, to name a few. The placement of many implants, to minimize visible scarring, may involve creating one or more paths to the implant zone.Method5900 according to some implementations will now be described as illustrated inFIG.59. The implementations and embodiments fromFIGS.54 and55 involving the treatment of cellulite are incorporated herein and may be modified as follows.
Implementation5900 to place a cosmetic implant may use same route(s) as for cellulite treatment, however, the tip may be deployed to its treatment configuration closer to implant zone. The width of the path and the entrance incision is preferably the minimum size needed for the implant to traverse the path from the opening incision to the implant pocket. In some implementations, the surgeon may have to open up an additional incision to place implant; this may depend upon whether the implant has a capsule or has gel that will be moved to through the path to the pocket. The surgeon may create a pocket appropriately sized for the implant to rest.
Step5905 comprises making an entrance incision. In some implementations,step5905 may comprises making a stab incision in a location that is not usually visible to the eye from a reasonable distance, for example, the umbilicus/bellybutton and/or under the axilla and/or around the nipple in the case of a breast implant. The width of the entrance incision is preferably the minimum size needed for the TD tip and shaft to traverse the entrance incision. Although the implant may be of a larger diameter, it may be preferable for optimizing traction keep the entrance incision its minimum size until the path to the implant zone and/or the implant pocket are created.
Step5910 may comprise forming a tip deployment pocket similar to that depicted in5411aatFIG.54 for receipt and/or reconfiguring of the lysing tip from its delivery configuration to its treatment configuration. In some implementations, curved blunt scissors may be used to make this tip deployment pocket by for example inserting said scissors up to its pivot point and/or opening/closing the scissors. In some implementations, the tip deployment pocket may be approximately the size of half of a postage stamp. For example, the tip deployment pocket may have a width in the direction of the incision of about 1 cm. Similarly, the tip deployment pocket may have a length perpendicular to the width of between about 1 cm to 2 cm. In some implementations, the surgeon may desire to open an additional incision to place the implant; this may depend upon whether the implant has a capsule or has gel that will be moved to through the path to the pocket.
Step5915 may comprise reconfiguring the lysing tip within the tip deployment pocket for receipt and/or reconfiguring of the lysing tip from its delivery configuration to its treatment In some implementations, a surgeon may make such a wide entrance incision that the lysing tip may even fit through the incision in the treatment configuration. In some implementations, the TD may be deployed through a cannula and once within the tip deployment pocket may be reconfigured from its delivery configuration to its treatment configuration. In other implementations, the lysing tip and/or grasping/control means may be inserted through the incision to the tip deployment pocket in which the lysing tip and grasping/control means may be coupled together in the treatment configuration.
Step5920 may comprise forming one or more paths to one or more implant zones as depicted inFIG.54a. In some implementations, this may comprise activating one or more lysing members and then advancing the lysing tip towards the implant zone. This may be done for example in a series of substeps by advancing the lysing tip and pulling it back in a repeated fashion. The surgeon may create additional paths adjacent to the initial path, thus creating a triangular and/or cone shape between the incision and the implant zone. As shown inFIG.54a, if thetreatment zone5402 has a width wider than the width of the path, the surgeon may, either right before or simultaneously with movement of the tip into the treatment zone, manipulate the treatment zone, such as by traction (either manual or using instrumentation), into the path of the lysing tip. The width of the path may be the minimum dimensions needed for the implant to traverse the path.
Step5921 may comprise the surgeon creating an implant pocket appropriately sized for the implant to rest.
Step5922, perhaps after removal of the TD, may comprise expanding the entrance incision to the minimum dimensions required for the maximum dimension of the implant to traverse the entrance incision.
Step5925 may comprise, after lysing the tissues, applying energy to the implant zone with the TD or a separate TMT. In some implementations, a surgeon may reduce bleeding by use of such instruments as a bovie probe and/or grasper/clamp. In alternative implementations, the surgeon may use the lysing members of the lysing tip and/or the energy window of the TMT to modify tissues for various intended results, including but not limited to skin tightening and fat modification. In such implementations, the energy window of the TMT may be configured to deliver the following types of energy modalities including but not limited to laser, intense pulse light, resistive heating, radiant heat, thermochromic, ultrasound, and/or microwave.
Step5930 may comprise rotating and/or reconfiguring the lysing tip back into the delivery configuration in either the treatment area and/or the tip deployment pocket and/or the path, if it is sufficiently wide, and withdrawing the lysing tip and/or cannula back through the incision.
Step5935 may comprise delivery and/or placement and/or securing of the implant according to manufacturers' recommendations and/or specifications and/or qualified surgeons' modifications. Securing of the implant may include, but not be limited to, placing sutures, staples, and/or retention devices either in the tissues around the implant and/or along the tissues along the path of the implant and/or the tissues along the entrance incision.
Step5940 may comprise closing the entrance wounds or surface incisions via glues, staples, adhesive skin closure strips, and/or sutures.
An example of amethod6000 for a capsulotomy and/or a capsulectomy will now be described as illustrated inFIG.60. As breast implants may be viewed by the human body as a foreign object, scar tissue may develop around a breast implant over a 3 to 4 year period. This capsule of scar/fibrous tissue may be of a spherical shape.Step6005 may comprise making an entrance incision as previously described herein.Step6010 may comprise creating a tip deployment pocket near to or away from the entrance incision as previously described herein.Step6015 may comprise inserting the TD in its delivery configuration and re-configuring the TD to its treatment configuration as previously described herein.Step6020 may comprise activating the TD and creating paths to the treatment zone, in this embodiment, around the capsule.Step6025 may comprise activating the TD and lysing the adhesions attaching to the capsule to the implant and/or surrounding tissues by moving along the periphery of capsule.Step6028 may comprise returning the lysing tip to a deployment configuration.Step6030 may comprise removal of the TD as previously described herein.Step6035 may comprise separation and/or removal of at least a portion of the capsule from the surrounding tissues and/or the implant. In some implementations,step6035 may be performed beforestep6030.
Step6035 may comprise withdrawal of the lysing tip. Step6040 may comprise closing the entrance wounds or surface incisions via glues, staples, adhesive skin closure strips, and/or sutures.
An example of amethod6100 for body lifting and skin excision will now be described as illustrated inFIG.61. An example of a use of this method includes tightening of sagging tissue on arms. Generally, this procedure involves undermining skin, excising a portion of said skin, and pulling tight the remaining skin.
Step6105 may comprise making the skin incision near the undermining zone as previously described herein which may be under the arm pit and hydrating/tumescent the area to be undermined as stated previously. The area to be undermined may be 10 to 20 cm beyond the location of the incision demarking the skin to be removed.Step6110 may comprise widening the entrance incision and creating the tip deployment pocket as stated previously.Step6115 may comprise inserting the lysing tip in its delivery configuration into the tip deployment pocket and deploying the lysing tip to the treatment configuration.
Step6120 may comprise undermining/lysing skin in locations beneath the skin to be removed as well as locations adjacent thereto in order to have sufficient tissue to pull the edges of the remaining tissue together to be closed. In this step, fat may be heated/removed as well.Step6125 may comprise withdrawal of the lysing tip.
Step6130 may comprise making the incision, which may be in the form of an ellipse, demarking the edges of the tissue to be removed.Step6135 may comprise removal of the tissue comprising the shape of the ellipse.Step6140 may comprise sewing fascia together to take the stress off of the skin when the edges of the skin are sewn together.Step6145 may comprise closing wounds or surface incisions via glues, staples, adhesive skin closure strips, and/or sutures.
Modification of localized cutaneous neurologic symptoms. E.g., localized itching or burning. E.g., Notalgia paresthetica is an intense localized itching area usually on the back. Dissecting the skin in the NP area as well as around it may denervate or alter the neurologic pattern in area thus may provide relief. Post zoster neuralgia is an often painful condition that may feel like it is coming from the skin in patients who have suffered from shingles. Dissecting the skin in the post zoster neuralgia area as well as around it may denervate or alter the neurologic pattern in area thus may provide relief. Other itching and painful conditions of the skin possibly related to neurologic alterations may be improved by dissection with TD.
It will be understood by those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles presented herein. For example, any suitable combination of various embodiments, or the features thereof, is contemplated.
Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.
Throughout this specification, any reference to “one embodiment,” “an embodiment,” or “the embodiment” means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.
Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles set forth herein.
Furthermore, the described features, components, structures, steps, or characteristics may be combined in any suitable manner in one or more alternative embodiments and/or implementations. In other words, any of the features, components, structures, steps, or characteristics disclosed in any one disclosed embodiment may be combined with features, components, structures, steps, or characteristics of other disclosed embodiments. The scope of the present invention should, therefore, be determined only by the following claims.